Methods for treating pancreatic cancer in an individual, for diagnosing and treating pancreatic cancer in an individual and for monitoring protein or peptide fragments in an individual and treating pancreatic cancer in an individual, kit for diagnosing pancreatic cancer in an individual, method implemented by computer to process a biological sample from an individual, diagnose pancreatic cancer and treat pancreatic cancer, and, proteolyzed sample for use in mass spectrometry to diagnose pancreatic cancer in an individual

Description

METHODS FOR TREATING PANCREATIC CANCER IN AN INDIVIDUAL, FOR DIAGNOSING AND TREATING PANCREATIC CANCER IN AN INDIVIDUAL, AND FOR MONITORING PROTEIN OR PEPTIDE FRAGMENTS IN AN INDIVIDUAL AND TREATING PANCREATIC CANCER IN AN INDIVIDUAL, KIT FOR DIAGNOSING PANCREATIC CANCER, COMPUTER-IMPLEMENTED METHOD FOR PROCESSING A BIOLOGICAL SAMPLE FROM AN INDIVIDUAL, DIAGNOSING PANCREATIC CANCER AND TREATING PANCREATIC CANCER, AND PROTEOLYZED SAMPLE FOR USE IN MASS SPECTROMETRY TO DIAGNOSE PANCREATIC CANCER. PANCREAS IN AN INDIVIDUAL TECHNICAL FIELD

[001] This description refers generally to the field of diagnosing and treating pancreatic cancer. FUNDAMENTALS

[002] Pancreatic cancer has a poor prognosis. This is often because early detection is difficult. Patients usually do not experience symptoms until the cancer becomes untreatable and / or has spread throughout the body. In addition, the tumors are difficult to visualize because they are located deep within the body.

[003] In order to diagnose the disease early, genetic testing is performed on patients with a family history of the disease. These tests examine genetic alterations that cause hereditary conditions. However, these tests have limitations in their ability to predict the risk of pancreatic cancer. For individuals identified as having a risk of developing pancreatic cancer through genetic testing, endoscopic ultrasound or magnetic resonance imaging (MRI) is still used to assess the likelihood of pancreatic cancer. Although doctors Petition 870250095163, dated 10 / 17 / 2025, pp. 92 / 185 / 61, although they have been able to detect pancreatic cancers early and treatably in individuals predisposed to developing pancreatic cancer through genetic analysis, such tests are not used for screening the general public. (See American Cancer Society: www.cancer.org / cancer / pancreatic-cancer / detection-diagnosisstaging / detection.html).

[004] Furthermore, few drugs are available to treat pancreatic cancer. In recent years, several targeted agents have been tested, such as ECFR inhibitors (erlotinib), VEGF and VEGFR inhibitors, phosphoinositide-3-kinase-mTOR pathway inhibitors, Janus kinase inhibitors, and Ras pathway inhibitors. Unfortunately, most of these agents have been ineffective in treating the disease (Zhu et al., 2018, “Pancreatic cancer: challenges and opportunities”, BMC Medicine 16(214)).

[005] Consequently, pancreatic cancer is not only difficult to detect early, but remains one of the most untreatable forms of cancer in humans.

[006] Thus, there is a need for an improved method for diagnosing pancreatic cancer and / or for determining an individual's predisposition to developing pancreatic cancer and treating it. There is also a need for screening and treating individuals with early-stage pancreatic cancer (e.g., stage 1 or 2). SUMMARY

[007] The present description provides a method for diagnosing and treating or causing the treatment of pancreatic cancer.

[008] According to the present description, a new proteomic profile for pancreatic cancer is used to diagnose, treat and / or improve pancreatic cancer. In some modalities, treatment comprises surgery to remove the tumor or, optionally, administering an anticancer therapeutic agent, for example, to reduce the progression of Petition 870250095163, dated 10 / 17 / 2025, page 93 / 185 / 61 pancreatic cancer. In additional or alternative modalities, the new proteomic profile is used to monitor disease progression and / or remission.

[009] The proteomic profile for pancreatic cancer comprises at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b or complement factor C6, and fibronectin. In one embodiment, an individual is diagnosed with pancreatic cancer by determining whether one, two, three, four, five, six, seven, or more of the proteins are elevated, such as, for example, elevated at least 1.2 times, 1.4 times, 1.6 times, 1.8 times, 2.0 times, or more relative to a level considered normal (e.g., a baseline) in one or more individuals without pancreatic cancer.

[0010] Surprisingly, it has been found that the proteomic profile comprising a plurality of the preceding proteins or peptide fragments is elevated in an individual with early-stage (stage 1) pancreatic cancer compared to an individual negative for pancreatic cancer. In some embodiments, the levels of pancreatic cancer-related proteins are elevated in the circulation of the individual with pancreatic cancer compared to an individual without pancreatic cancer. In additional embodiments, the levels of pancreatic cancer-related proteins in the individual's circulation are monitored in the manner described herein, and if changes over time are detected, the individual is identified for further evaluation. In certain embodiments, the levels of pancreatic cancer-related proteins are altered in the blood (e.g., serum, plasma), body fluids (e.g., fluid Petition 870250095163, dated 10 / 17 / 2025, page 94 / 185 / 61 cerebrospinal fluid, pleural fluid, amniotic fluid, semen or saliva), urine and / or feces of the individual with pancreatic cancer. Without getting bogged down in theory, it is believed that the new combination of proteins related to pancreatic cancer plays a role in the development of pancreatic cancer. The treatment method may additionally include one or more steps of obtaining a biopsy to positively confirm the presence of pancreatic cancer, followed by surgery and / or administration of a drug for pancreatic cancer. Typically, treatment comprises a combination of biopsy and surgery after a positive diagnosis.

[0011] According to one aspect of the description, a method is provided for treating pancreatic cancer in an individual, the method comprising: (i) obtaining a proteomic profile from an individual, the proteomic profile previously obtained by: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of one or a combination of at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the sample obtained;(c) comparing the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a negative reference value for pancreatic cancer and / or from a sample obtained at an earlier point in time from the individual; (ii) identifying the individual as being at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof; Petition 870250095163, dated 10 / 17 / 2025, page 95 / 185 / 61 same, if the sample obtained differs in relation to the concentration levels of the reference pancreatic cancer-related proteins or peptide fragments thereof, from the negative reference value for pancreatic cancer and / or from a sample obtained at an earlier point in time from the individual; (iii) optionally obtain a biopsy of the individual thus identified as being at risk of having pancreatic cancer in step (ii); (iv) analyze the biopsy to determine if cancer cells are present; (v) identify the individual as having pancreatic cancer if the individual is identified as being at risk of having pancreatic cancer based on the proteomic profile in step (ii) and if cancer cells are present in the biopsy; and (vi) optionally remove cancerous tissue from the pancreas and / or bile duct(s) of the individual if the individual is identified as having pancreatic cancer.

[0012] According to a further aspect of the description, a method is provided for diagnosing and treating pancreatic cancer in an individual, the method comprising: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of one or a combination of at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the sample obtained;(c) compare the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of a pancreatic cancer-negative reference value and / or of a sample obtained; Petition 870250095163, of 10 / 17 / 2025, page 96 / 185 / 61 at a point in time prior to the individual's death; (d) identify the individual as having pancreatic cancer or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins or peptide fragments thereof, the negative reference value for pancreatic cancer, and / or a sample obtained at a point in time prior to the individual's death; and (e) optionally treat or cause the treatment of the individual thus identified as having pancreatic cancer with a pancreatic cancer treatment regimen, optionally comprising surgery and / or administration of a chemotherapeutic agent or radiotherapy.

[0013] According to a further aspect of the description, a method is provided for diagnosing and treating pancreatic cancer in an individual, the method comprising: (a) providing a biological sample obtained from the individual; (b) measuring or having measured in a spectroscopy unit the concentration levels of a combination of pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1; apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6 and fibronectin from the sample obtained;(c) compare or have compared concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, as determined in the spectroscopy unit, with reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a negative reference value for pancreatic cancer and / or from a sample obtained at an earlier point in time from the individual; (d) identify the individual as having cancer of; Petition 870250095163, of 10 / 17 / 2025, page 97 / 185 / 61 pancreas or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the pancreatic cancer-negative sample and / or in a sample obtained at an earlier point in time from the individual; and (e) optionally treat or cause the treatment of the individual thus identified as having pancreatic cancer with a pancreatic cancer treatment regimen, optionally comprising surgery and / or administration of a chemotherapeutic agent or radiotherapy.

[0014] In one embodiment, the treatment of pancreatic cancer comprises reducing blood levels of one or more of the proteins related to pancreatic cancer, or peptide fragments thereof, in the individual diagnosed as having pancreatic cancer.

[0015] According to any of the preceding aspects or modalities, the adjustment of blood levels of one or more of the pancreatic cancer-related proteins, or peptide fragments thereof, in the individual occurs until the pancreatic cancer-related proteins, or peptide fragments thereof, are reduced to a predetermined level in the individual.

[0016] In accordance with any of the preceding aspects or modalities, the identification step occurs after determining that the concentration levels of at least one, at least two, at least three, at least four, or at least five of the pancreatic cancer-related proteins, or peptide fragments thereof, in the obtained sample are elevated by approximately 10% or more, 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the concentration levels of the reference pancreatic cancer-related proteins, or peptide fragments. Petition 870250095163, dated 10 / 17 / 2025, page 98 / 185 / 61 of the same, regarding the negative reference value for pancreatic cancer and / or in relation to concentration levels in a sample previously obtained from the individual.

[0017] According to any of the preceding aspects or embodiments, measuring the concentration levels of pancreatic cancer-related proteins or peptide fragments comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

[0018] In accordance with any of the preceding aspects or modalities, the concentration level of at least tetranectin is measured.

[0019] In accordance with any of the preceding aspects or modalities, the sample obtained is blood or urine.

[0020] According to any of the preceding aspects or modalities, the sample obtained is serum or plasma.

[0021] In accordance with any of the preceding aspects or modalities, the sample obtained is urine.

[0022] In accordance with any of the preceding aspects or modalities, pancreatic cancer-related proteins, or peptide fragments thereof, are measured by a spectroscopic technique, wherein the spectroscopic technique is selected from the group consisting of liquid chromatography, gas chromatography, liquid chromatography mass spectrometry, gas chromatography mass spectrometry, high-performance liquid chromatography mass spectrometry, capillary electrophoresis mass spectrometry, nuclear magnetic resonance (NMR) spectrometry, Raman spectrometry and infrared spectrometry.

[0023] According to any of the preceding aspects or modalities, the spectroscopic technique comprises mass spectrometry.

[0024] According to any of the aspects or modalities Petition 870250095163, dated 10 / 17 / 2025, page 99 / 185 / 61 precedents, the comparison of the concentration levels of proteins related to pancreatic cancer, or peptide fragments thereof, or peptide fragments thereof, of the sample obtained with the concentration levels of the reference values ​​involves using multivariate statistical analysis.

[0025] In accordance with any of the preceding aspects or modalities, the multivariate statistical analysis is selected from principal component analysis (PCA), or partial least squares designs for discriminant analysis of latent structures (PLS-DA).

[0026] According to another aspect of the description, a method is provided for monitoring protein or peptide fragments in an individual and treating pancreatic cancer in an individual, the method comprising: (a) providing a first biological sample obtained from the individual at a first point in time; (b) assessing a first proteomic profile related to pancreatic cancer by measuring the concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1;(a) apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the first biological sample; (c) compare the first pancreatic cancer-related proteomic profile with a reference pancreatic cancer-related proteomic profile from a pancreatic cancer-negative sample; (d) determine that there is a first difference between the first pancreatic cancer-related proteomic profile and the reference pancreatic cancer-related proteomic profile from; Petition 870250095163, dated 10 / 17 / 2025, page 100 / 185 / 61 reference sample negative for pancreatic cancer, the first difference being indicative of pancreatic cancer; (e) provide a second biological sample obtained from the individual at a second point in time that is after the first point in time; (f) evaluate a second proteomic profile related to pancreatic cancer by measuring the concentration levels of proteins related to pancreatic cancer, or peptide fragments thereof, from the second biological sample; (g) compare the second proteomic profile related to pancreatic cancer with the reference proteomic profile related to pancreatic cancer from the sample negative for pancreatic cancer;(h) determine that there is a second difference between the first pancreatic cancer-related proteomic profile and the reference pancreatic cancer-related proteomic profile of the pancreatic cancer-negative sample, the second difference being indicative of pancreatic cancer; (i) determine pancreatic cancer progression or a risk of having pancreatic cancer based at least in part on the first and second differences; and (j) optionally treat or cause the treatment of the individual if identified as having pancreatic cancer with a pancreatic cancer treatment regimen, optionally comprising surgery and / or administration of an anticancer therapeutic agent or radiotherapy.

[0027] According to the preceding aspect, in some modalities, the time period between the first and second points in time is at least 1 month, at least 2 months, at least 3 months or at least 6 months.

[0028] According to the preceding aspect or embodiments thereof, measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the first and / or second biological samples comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin. Petition 870250095163, dated 10 / 17 / 2025, pp. 101 / 185 11 / 61

[0029] In accordance with the preceding aspect or modalities thereof, the concentration level of at least tetranectin is measured.

[0030] According to the preceding aspect or modalities thereof, the first sample, the second sample, or both are blood or urine, or wherein both samples are the same type of specimen and are selected from serum, plasma, or urine.

[0031] According to a further aspect of the description, a pancreatic cancer diagnostic kit is provided comprising: (a) a detector configured to detect concentration levels of at least one, at least two, at least three, at least four or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1; apolipoprotein A-II, plasma protease inhibitor C11, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C11s, complement factor C4b, complement factor C6 and fibronectin obtained from a biological sample; (b) a composition comprising apolipoprotein A1;apolipoprotein A-II, plasma protease inhibitor Cl, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cls, complement factor C4b, complement factor C6, and fibronectin at control levels corresponding to a control group of individuals negative for pancreatic cancer; (c) a multivariate analysis system configured to analyze a difference in the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, and control levels; and (d) optionally, provide instructions for a pancreatic cancer diagnostic method, wherein the method comprises measuring, using the detector, the levels of pancreatic cancer-related proteins, or peptide fragments thereof; Petition 870250095163, dated 10 / 17 / 2025, pp. 102 / 185 12 / 61 from the biological sample obtained, and compare the levels of pancreatic cancer-related proteins obtained, or peptide fragments thereof, with control levels of pancreatic cancer-related proteins, or peptide fragments thereof, obtained from individuals negative for pancreatic cancer and / or from a sample obtained at an earlier point in time from the individual.

[0032] According to an embodiment of the preceding aspect of the description, the detector comprises a multiproteomic detector configured to measure the levels of pancreatic cancer-related proteins, or peptide fragments thereof, comprising apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor Cl, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cls, complement factor C4b, complement factor C6 and fibronectin.

[0033] In some embodiments of the preceding aspect or embodiments thereof, the detector is configured to measure the concentration levels of pancreatic cancer-related proteins or peptide fragments comprising at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

[0034] In some embodiments of the preceding aspect or embodiments thereof, the detector is configured to measure at least tetranectin.

[0035] According to a further aspect of the description, a computer-implemented method is provided for processing a biological sample from an individual, diagnosing pancreatic cancer and treating pancreatic cancer, the computer-implemented method comprising: (a) receiving a biological sample obtained from the individual; (b) processing the sample Petition 870250095163, dated 10 / 17 / 2025, page 103 / 185 / 61 in a spectroscopy unit connected directly or wirelessly to a processing device, the processing device having memory to store measurement data from the spectroscopy unit; (c) in the spectroscopy unit, measure the levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s,(a) Complement factor C4b or complement factor C6 and fibronectin and store the measurement data in the processor; (d) Compare the stored measurement data to a reference value in memory that represents a negative sample for pancreatic cancer, optionally using multivariate statistical analysis; (e) Store, in the processing device, a result that corresponds to at least one, at least two, at least three, at least four, or at least five proteins related to pancreatic cancer, or peptide fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b or complement factor C6, and fibronectin from the obtained sample.wherein the result identifies the individual as having pancreatic cancer or at risk of having pancreatic cancer if the measurement data representing the levels of pancreatic cancer-related proteins, or peptide fragments thereof, are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a pancreatic cancer-negative sample; (f) display the, Petition 870250095163, dated 10 / 17 / 2025, page 104 / 185 / 61 result in an electronic display connected directly or wirelessly to a processor for the individual identified as having pancreatic cancer, at risk of having pancreatic cancer, or as having a predisposition to developing pancreatic cancer; and (g) optionally treat or cause treatment of the individual identified as having pancreatic cancer with a regimen for pancreatic cancer, optionally comprising surgery and / or administration of an anticancer therapeutic agent or radiotherapy.

[0036] In some embodiments of the preceding aspect or embodiments thereof, the displayed result is included in a user interface, which is a control panel.

[0037] In some embodiments of the preceding aspect or embodiments thereof, the displayed result is part of multiomic information displayed in the user interface.

[0038] In some embodiments of the preceding aspect or embodiments thereof, the spectroscopy unit comprises a detector or is operationally connected to a detector that is configured to measure the concentration levels of pancreatic cancer-related proteins or peptide fragments optionally configured to measure at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

[0039] In some embodiments of the preceding aspect or embodiments thereof, the detector is configured to measure at least tetranectin.

[0040] According to a further aspect of the description, a method is provided for diagnosing and treating pancreatic cancer in an individual, the method comprising: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of at least one, at least two, at least three, at least four, or at least five proteins related to pancreatic cancer, or peptide fragments of the Petition 870250095163, dated 10 / 17 / 2025, page 105 / 185 / 61 same, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b or complement factor C6 and fibronectin; (c) compare the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a pancreatic cancer-negative sample and / or from a sample obtained at an earlier point in time from the individual;(d) identify the individual as having pancreatic cancer or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in a pancreatic cancer-negative sample and / or a sample obtained at an earlier point in time from the individual; and (e) optionally treat or cause the treatment of the individual so identified with a pancreatic cancer treatment regimen or radiotherapy.

[0041] In some embodiments of the preceding aspect or embodiments thereof, measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the first and / or second biological samples comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

[0042] In some embodiments of the preceding aspect or embodiments thereof, the concentration level of at least tetranectin is measured. Petition 870250095163, dated 10 / 17 / 2025, page 106 / 185 / 61

[0043] According to a further aspect of the description, a method is provided for diagnosing and treating pancreatic cancer in an individual, the method comprising: (a) providing a first biological sample obtained from the individual; (b) at a first point in time, measuring the concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b or complement factor C6, and fibronectin from the sample obtained;(c) compare the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a pancreatic cancer-negative sample and / or a sample obtained at a previous time point in the individual; (d) at a second time point, measure the concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1;apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b or complement factor C6, and fibronectin in a second biological sample obtained from the individual; (e) compare the concentration levels at the second time point of pancreatic cancer-related proteins, or peptide fragments thereof, from the sample obtained with the protein concentration levels; Petition 870250095163, dated 10 / 17 / 2025, page 107 / 185 / 61 related to reference pancreatic cancer, or peptide fragments thereof, from a sample negative for pancreatic cancer and / or from a sample obtained at the first point in time or at the previous point in time of the individual; (f) identify the individual as having pancreatic cancer or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the first and second samples obtained are different from the concentration levels of reference pancreatic cancer-related proteins, or peptide fragments thereof, from the pancreatic cancer-negative sample, and / or from a sample obtained at the first point in time; and (g) optionally treat or cause the treatment of the individual if so identified as having pancreatic cancer with a pancreatic cancer treatment regimen.

[0044] In some embodiments of the preceding aspect or embodiments thereof, the identification step (f) occurs after it has been determined that the concentration levels of at least one, at least two, at least three, at least four, or at least five of the pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are elevated by about 10% or more, about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the concentration levels of the reference pancreatic cancer-related proteins, or peptide fragments thereof, in the pancreatic cancer-negative sample.

[0045] In some embodiments of the preceding aspect or embodiments thereof, the identification step (f) occurs after determining that the concentration levels of at least three, at least four, or at least five of the pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are Petition 870250095163, dated 10 / 17 / 2025, page 108 / 185 / 61 elevated by approximately 10% or more, approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more in relation to the concentration levels of reference pancreatic cancer-related proteins, or peptide fragments thereof, of the pancreatic cancer-negative sample.

[0046] In some embodiments of the preceding aspect or embodiments thereof, measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the first and / or second biological samples comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

[0047] In some embodiments of the preceding aspect or embodiments thereof, the concentration level of at least tetranectin is measured.

[0048] In some embodiments of the preceding aspect or embodiments thereof, the sample obtained is blood or urine, or is serum, plasma or urine.

[0049] In some embodiments of the preceding aspect or embodiments thereof, pancreatic cancer-related proteins, or peptide fragments thereof, are measured by a spectroscopic technique, wherein the spectroscopic technique is selected from the group consisting of liquid chromatography, gas chromatography, liquid chromatography mass spectrometry, gas chromatography mass spectrometry, high-performance liquid chromatography mass spectrometry, capillary electrophoresis mass spectrometry, nuclear magnetic resonance (NMR) spectrometry, Raman spectrometry and infrared spectrometry.

[0050] In some embodiments of the preceding aspect or embodiments thereof, the comparison of concentration levels of Petition 870250095163, dated 10 / 17 / 2025, page 109 / 185 / 61 proteins related to pancreatic cancer, or peptide fragments thereof, from the sample obtained with the reference concentration levels of proteins related to pancreatic cancer, or peptide fragments thereof, from the sample negative for pancreatic cancer comprises multivariate statistical analysis.

[0051] In some embodiments of the preceding aspect or embodiments thereof, measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the second biological sample comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, and phospholipid transfer protein, and wherein if the measured levels of L-selectin, tetranectin, and / or phospholipid transfer protein in the second biological sample, when compared to the respective concentration levels measured at the first point in time, are elevated by at least 10%, 15%, 20%, or 25%, the individual is identified as having pancreatic cancer or as having a risk of having pancreatic cancer.

[0052] In some embodiments of the preceding aspect or embodiments thereof, the concentration level of at least fibronectin is measured, and wherein if the measured level of fibronectin in the second biological sample, when compared to a respective concentration level measured at the first point in time, is elevated or decreased by at least 10%, 15%, 20% or 25%, the individual is identified as having pancreatic cancer or as having a risk of having pancreatic cancer.

[0053] According to a further aspect, a proteolyzed sample is provided for use in mass spectrometry to diagnose pancreatic cancer in an individual comprising one or a combination of peptide fragments of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, membrane-associated protein Petition 870250095163, dated 10 / 17 / 2025, page 110 / 185 / 61 adipocyte plasma, complement factor C1s, complement factor C4b, complement factor C6 and fibronectin.

[0054] According to a further aspect, a proteolyzed sample is provided for use in mass spectrometry to diagnose pancreatic cancer in an individual comprising a peptide fragment of L-selectin, tetranectin, phospholipid transfer protein and / or fibronectin.

[0055] In some embodiments of any of the preceding aspects or embodiments thereof, the method further comprises obtaining a biopsy sample from the individual identified as having a risk of having pancreatic cancer after measuring pancreatic cancer proteins, or fragments thereof, and, if cancer cells are identified in the sample, surgically removing cancerous tissue from the pancreas and / or bile duct(s) of the individual.

[0056] In some alternative embodiments of any of the preceding aspects or embodiments thereof, tetranectin levels increase over time, in the manner measured at two or more time points over a period of 1 month to 3 years, or are elevated at a single time point relative to a control, thereby identifying the individual as having pancreatic cancer (e.g., stage 1). Such an embodiment may further comprise measuring levels of at least one of L-selectin and phospholipid transfer protein, wherein the levels of at least one of L-selectin and phospholipid transfer protein increase over time, in the manner measured at two or more time points over a period of 1 month to 3 years, or are elevated at a single time point relative to a control. In some embodiments, the method or kit further comprises measuring fibronectin.In some embodiments, the method additionally comprises measuring at least one apolipoprotein A1, apolipoprotein A-II, or protease inhibitor. Petition 870250095163, dated 10 / 17 / 2025, page 111 / 185 / 61 Plasma C1, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, or a combination thereof.

[0057] All the exemplary embodiments described in this description that are not mutually exclusive can be combined with each other. Elements of one embodiment can be used in other embodiments without further mention. Other aspects and features of the present description will become apparent to those skilled in the art by reviewing the following description of specific embodiments in conjunction with the attached figure. BRIEF DESCRIPTION OF THE DRAWING

[0058] Figure 1 describes the steps of the method according to one embodiment of the description. DETAILED DESCRIPTION

[0059] A detailed description of one or more embodiments of the invention is provided below. The invention is described in connection with such embodiments, but the invention is not limited to any specific embodiment described herein. The scope of the invention is limited only by the claims and their equivalents. Numerous specific details are presented in the following description to provide a complete understanding of the invention. These details are provided for the purpose of providing non-limiting examples, and the invention can be practiced in accordance with the claims without some or all of these specific details. Definitions

[0060] Unless otherwise defined, all technical and scientific terms used herein have the same meaning commonly understood by those skilled in the art to whom the present invention relates. As used herein, and unless otherwise indicated or required by the context, each of the following terms shall have the definition Petition 870250095163, dated 10 / 17 / 2025, page 112 / 185 / 61 presented below.

[0061] Articles such as “a” and “an”, when used in a claim, are understood to mean one or more of the items claimed or described.

[0062] The term “negative for pancreatic cancer”, with reference to a sample, generally refers to a biological sample from an individual who does not have pancreatic cancer or is not predisposed to developing pancreatic cancer.

[0063] The term “baseline” or “control” generally refers to a value corresponding to the concentration of a protein, or peptide fragment thereof, in an individual who does not have pancreatic cancer or is not predisposed to developing pancreatic cancer, or to a value derived from a population of such individuals and / or from published data.

[0064] The term “pancreatic cancer treatment regimen” generally refers to an intervention undertaken in response to an individual suffering from pancreatic cancer. The aim of the regimen may include, but is not limited to, one or more of the following: relief or prevention of symptoms, slowing or halting the progression or worsening of pancreatic cancer, and remission of pancreatic cancer.

[0065] In some modalities, “pancreatic cancer treatment regimen” refers to therapeutic treatment (e.g., alteration of proteomic levels related to pancreatic cancer) by one or more appropriate therapeutic agents administered to a patient, such as chemotherapeutic agents.

[0066] The terms “comprises”, “comprising”, “include”, “includes”, “including”, “contains”, “contains” and “containing” are not limiting, i.e., other steps and other sections that do not affect the final result may be added. The preceding terms include the terms “consisting of” and “consisting essentially of”. Petition 870250095163, dated 10 / 17 / 2025, pp. 113 / 185 23 / 61

[0067] The term “pancreatic cancer-related proteome” or “proteomic profile” generally refers to a profile of proteins associated with pancreatic cancer, comprising a plurality of proteins comprising at least one of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor Cl, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cls, complement factor C4b, complement factor C6, and fibronectin, or a combination thereof.

[0068] The expression “reference value derived from this”, in connection with the comparison of the level of a protein in a sample with a reference, refers to a value derived from a sample or a plurality of individuals who do not have pancreatic cancer. For example, the reference value may be derived from previously collected statistical data from individuals who do not have pancreatic cancer.

[0069] The terms “prevent” and “prevention” are used interchangeably and generally refer to any activity that leads to a reduction in the risk of developing pancreatic cancer in an individual.

[0070] The term “individual” generally refers to a vertebrate, such as a mammal. The term “mammal” is defined as an individual belonging to the class Mammalia. In some modalities, the individual is human.

[0071] The term “treat” or “treatment” generally refers to an intervention performed in response to pancreatic cancer or symptoms associated with it. The goal of treatment may include, but is not limited to, one or more of the following: relief or prevention of pancreatic cancer, slowing or halting the progression or worsening of pancreatic cancer, and remission of pancreatic cancer. In certain modalities, Petition 870250095163, dated 10 / 17 / 2025, page 114 / 185 / 61 “treatment” refers to surgery and / or administration of a therapeutic agent for the treatment of pancreatic cancer. Such treatment may also include radiotherapy.

[0072] The term “pancreatic cancer drug” refers to any therapeutic agent or prodrug used to treat or slow the progression of pancreatic cancer. The drug may be included in a pharmaceutical formulation and may optionally comprise excipients.

[0073] The term “biopsy”, as used herein with reference to determining whether an individual has pancreatic cancer, refers to a composition comprising cells and / or fluids, without limitation, from one or more of the following: duodenum, bile ducts, pancreas and / or pancreatic duct of the individual.

[0074] The term “preferred” or “preferably” refers to a non-limiting example of the description and should not be interpreted as limiting.

[0075] The term “computer implemented”, with reference to a method or process, means that all or a significant part of the steps of the method are performed by an electronic data processor and / or by distributed computing, such as cloud computing.

[0076] In all embodiments of this description, all percentages, concentrations, parts and proportions are based on the total weight of the compositions of this description, unless otherwise specified. All weights relating to listed ingredients are based on the active level and therefore do not include solvents or by-products that may be present in commercially available materials, unless otherwise specified. Modeling data

[0077] In one modality, between 1 and 50, 2 and 40, or 5 and 30 biomarkers are evaluated based on cancer modeling data from Petition 870250095163, dated 10 / 17 / 2025, pp. 115 / 185 / 61 pancreas. This data is used to assess whether a given biomarker is predictive of pancreatic cancer.

[0078] In one embodiment, modeling data are obtained from data from a pancreatic cancer trial and a control group, with each data point from the group subjected to a computer-implemented calculation comprising at least one of the following: a computer-generated ROC (Receiver Operating Characteristic) curve analysis, a Principal Component Analysis (PCA) plot, and a Latent Structures Discriminant Analysis (PLS-DA) model and / or a Variable Importance of Projection (VIP) plot, thereby obtaining a set of at least 2, 3, 4, 5, 6, 7, 8, 9, 10 or more biomarkers identified as contributing to the diagnosis, development, or regression of pancreatic cancer relative to other measured biomarkers.In some embodiments, the description is based on identifying an individual as being at risk of developing pancreatic cancer by determining whether a biological sample from the patient shows elevated or reduced levels of a novel combination of proteins, or fragments thereof, identified by the inventors as predictive of the presence of pancreatic cancer. The identified individual is then subjected to one or more steps comprising obtaining a biopsy (e.g., cells and / or fluids from the duodenum, bile duct(s), pancreas, and / or pancreatic duct) and analyzing the biopsy for the presence of cancerous cells.

[0079] In some embodiments, biomarkers are pre-selected from proteomic profiles obtained by computational modeling. In some non-limiting examples, at least 2, 3, 4, or 5 proteomic biomarkers are measured. In other embodiments, up to 100, 95, 90, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, or 20 proteomic biomarkers are identified based on computational modeling. Optionally, this includes the selection of metabolomic biomarkers, in addition Petition 870250095163, dated 10 / 17 / 2025, pp. 116 / 185 / 61 of proteomic biomarkers.

[0080] In some modalities, biomarkers are selected from computational modeling based on assigning a weight to biomarkers in a proteomic profile and, optionally, based on a metabolic profile, with the weight based on the marker's ability to diagnose and / or assess the progression of pancreatic cancer. Method for Diagnosing and Treating Pancreatic Cancer

[0081] In one aspect, the present description relates to methods for the diagnosis and treatment (e.g., early) of pancreatic cancer and any associated symptoms in an individual. The description, in some embodiments, provides, at least in part, the identification of proteins or peptide fragments thereof that provide etiological data related to pancreatic cancer and provides an opportunity for the objective diagnosis of pancreatic cancer, based on proteins or peptides, which may lead to more effective therapy. Given the complexities of the interactions between genetics and environment, proteomic profiling, optionally in combination with other profiles (e.g., genomic and / or metabolomic profiling), may provide an approach to a better understanding of pancreatic cancer and the development of diagnostic tests that aid in individualized treatment decisions.In one embodiment, the method comprises a proteomic analysis within a multiomics analysis, which includes a proteomic analysis and a genomic and / or metabolomic analysis. The multiomics-based analysis has the advantage of identifying biomarker profiles derived from an individual's inherited genes, as well as capturing the interactions of the individual's current lifestyle behaviors (e.g., smoking, alcohol consumption, sleep habits, physical activity, and the like), gut microbiome, dietary and environmental factors that contribute to the unique protein profile of an individual with pancreatic cancer. The combination. Petition 870250095163, dated 10 / 17 / 2025, pp. 117 / 185 Early diagnosis and treatment of pancreatic cancer has the added advantage of increasing positive therapeutic outcomes. Methods are described here that allow the identification of novel proteomic profiles among individuals with pancreatic cancer, which serve to diagnose and treat these individuals. Therefore, this description provides a technical advancement.

[0082] With the present description, a novel proteomic profile for pancreatic cancer is identified in an individual with pancreatic cancer. The proteomic profile for pancreatic cancer comprises at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor Cl1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cl1, complement factor C4b or complement factor C6, and fibronectin.

[0083] Apolipoprotein Al is here identified as a biomarker for pancreatic cancer and, in some embodiments, is elevated to a level of approximately 1.2 to 10 times or more compared to a median reference apolipoprotein Al level in individuals negative for pancreatic cancer. In some embodiments, an elevated apolipoprotein Al level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer. Apolipoprotein Al is currently believed to be a tumor suppressor. Apolipoprotein Al (ApoAl) is a protein involved in lipid metabolism and has been studied for its potential role in pancreatic cancer.

[0084] Alternatively or additionally, the protein, apolipoprotein A-II, is identified here as a biomarker for pancreatic cancer and, in some embodiments, is elevated to a level of approximately 1.2 to Petition 870250095163, dated 10 / 17 / 2025, pp. 118 / 185 / 61 times or more compared to a median level of a reference apolipoprotein A-II in individuals negative for pancreatic cancer. In some modalities, an elevated apolipoprotein A-II level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0085] Alternatively or additionally, the plasma protease inhibitor C1 protein can be measured as a biomarker for pancreatic cancer. Plasma protease inhibitor C1 can be elevated to a level of approximately 1.2 to 10 times or more compared to a median level of a reference plasma protease inhibitor C1 in individuals negative for pancreatic cancer. In some embodiments, an elevated plasma protease inhibitor C1 level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer. Plasma protease inhibitor 1 (C1 inhibitor) is a protein involved in the regulation of the complement system, which is a component of the immune system.

[0086] Alternatively or additionally, the protein, L-selectin, can be measured as a biomarker for pancreatic cancer. L-selectin is a cell adhesion molecule that is expressed on the surface of immune cells and is involved in the migration of these cells to sites of inflammation.

[0087] In some embodiments, L-selectin is elevated to a level of approximately 1.2 to 10 times or more compared to a median level of a reference L-selectin in individuals negative for pancreatic cancer. In some embodiments, an elevated L-selectin level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0088] Alternatively or additionally, the protein tetranectin can be measured as a biomarker for pancreatic cancer. Tetranectin, also known as tissue factor activator inhibitor, is an inhibitor of the tissue factor activator pathway. Petition 870250095163, dated 10 / 17 / 2025, page 119 / 185 / 61 of plasminogen-2, is a protein involved in blood clotting and has also been shown to have antitumor properties. Tetranectin is produced by several cell types in the body, including endothelial cells, platelets, and monocytes. It is also found in various tissues, including the liver, lung, and placenta. In some embodiments, tetranectin is elevated to a level of approximately 1.2 to 10 times or more compared to a median reference tetranectin level in individuals negative for pancreatic cancer. In some embodiments, an elevated tetranectin level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0089] Alternatively or additionally, the protein, phospholipid transfer protein, can be measured as a biomarker for pancreatic cancer. In some embodiments, phospholipid transfer protein is elevated to a level of approximately 1.2 to 10 times or more compared to a median level of a reference phospholipid transfer protein in individuals negative for pancreatic cancer. In some embodiments, an elevated phospholipid transfer protein level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0090] Alternatively or additionally, the protein, Apolipoprotein M, can be measured as a biomarker for pancreatic cancer and in some embodiments is elevated to a level of approximately 1.2 to 10 times or more compared to a median reference Apolipoprotein M level in individuals negative for pancreatic cancer. In some embodiments, an elevated Apolipoprotein M level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0091] Alternatively or additionally, complement factor C1s can be measured as a biomarker for pancreatic cancer and in Petition 870250095163, dated 10 / 17 / 2025, page 120 / 185 / 61 in some modalities is elevated to a level of approximately 1.2 to 10 times or more compared to a median level of a reference complement factor C1s in individuals negative for pancreatic cancer. In some modalities, an elevated complement factor C1s level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0092] Alternatively or additionally, complement factor C4b can be measured as a biomarker for pancreatic cancer and in some modalities is elevated to a level of approximately 1.2 to 10 times or more compared to a median level of a reference complement factor C4b in individuals negative for pancreatic cancer. In some modalities, an elevated complement factor C4b level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0093] Alternatively or additionally, complement factor C6 can be measured as a biomarker for pancreatic cancer and in some modalities is elevated to a level of approximately 1.2 to 10 times or more compared to a median level of a reference complement factor C6 in individuals negative for pancreatic cancer. In some modalities, an elevated complement factor C6 level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0094] Alternatively or additionally, the protein, gelsolin, can be measured as a biomarker for pancreatic cancer. Gelsolin has established roles in cell motility and, in some embodiments, is elevated to a level of approximately 1.2 to 10 times or more compared to a median level of a reference gelsolin in individuals negative for pancreatic cancer. In some embodiments, an elevated gelsolin level of 1.2 times or more identifies the individual as having pancreatic cancer, such Petition 870250095163, dated 10 / 17 / 2025, page 121 / 185 / 61 as pancreatic cancer in stage 1 or 2.

[0095] Alternatively or additionally, adipocyte plasma membrane-associated protein (AMP) can be measured as a biomarker for pancreatic cancer. AMP, also known as adipophilin, is a protein expressed in lipid droplets, cellular organelles that store lipids such as fats. Adipophilin is expressed in adipose tissue (fat), and therefore weight loss can lead to decreased blood levels. Regular physical activity has been shown to reduce adipose tissue and therefore decrease blood adipophilin levels. Consuming a diet low in fat and high in fiber, fruits, and vegetables can help reduce blood adipophilin levels.Certain medications, such as statins, which are used to lower cholesterol levels, have been shown to reduce blood adipophilin levels and, in some forms, raise them to a level approximately 1.2 to 10 times or more compared to the median level of a reference adipocyte plasma membrane-associated protein in individuals without pancreatic cancer. In some forms, an elevated adipocyte plasma membrane-associated protein level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0096] Alternatively or additionally, the fibronectin protein can be measured as a biomarker for pancreatic cancer and, in some modalities, is elevated to a level of approximately 1.2 to 10 times or more compared to a median reference fibronectin level in individuals negative for pancreatic cancer. In some modalities, an elevated fibronectin level of 1.2 times or more identifies the individual as having pancreatic cancer, such as stage 1 or 2 pancreatic cancer.

[0097] In one aspect, the present description provides a method for diagnosing and treating pancreatic cancer in an individual. The method Petition 870250095163, dated 10 / 17 / 2025, page 122 / 185 / 61 comprises step (a) providing a biological sample obtained from the individual, such as a human being. According to the methods described herein, any type of biological sample from any part of an individual's body may be tested, including, but not limited to, blood (including, but not limited to, serum or plasma), cerebrospinal fluid (“CSF”), pleural fluid, urine, feces, sweat, tears, respiratory condensate, saliva, vitreous humor, a tissue sample, amniotic fluid, a chorionic villus sample, brain tissue, a biopsy of any solid tissue, including tumor, adjacent normal muscle, smooth and skeletal muscle, adipose tissue, liver, skin, hair, brain, kidney, pancreas, lung or the like. In one embodiment, the biological sample is obtained from blood.Proteins related to pancreatic cancer can be extracted from biological sources using any number of extraction / purification procedures that are typically used in quantitative analytical chemistry.

[0098] The method further comprises step (b), which includes measuring the concentration levels of at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins, or peptide fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the sample obtained. In certain embodiments, the method comprises measuring at least 8, 9, 10, 11, 12, 13, 14, or 15 pancreatic cancer-related proteins, or fragments thereof, from the sample obtained.

[0099] In certain embodiments, the method may additionally include measuring the concentration levels of one or more proteins related to Petition 870250095163, dated 10 / 17 / 2025, p. 123 / 185 / 61 additional pancreatic cancer, or peptide fragments thereof, in addition to the preceding proteins including, but not limited to, any of those known in the art. Such markers include carbohydrate antigen 19-9 (CA 19-9) (See Goonetilleke and Siriwardena, 2007, Eur J Surg Oncol. 33(3): 266-70, which is incorporated herein by reference), CA 242, hCG beta, CA 72-4 and carcinoembryonic antigen (CEA) (See Louhimo et al., 2004, Oncologia, 66(2):125-31, which is incorporated herein by reference).

[00100] The method described herein further comprises step (c) of comparing the concentration levels of pancreatic cancer-related proteins or their peptide fragments from the sample obtained with the concentration levels of reference pancreatic cancer-related proteins or their peptide fragments from pancreatic cancer-negative sample(s) or a reference value derived therefrom. Those skilled in the art will understand that references can be established as a representative value of the level of pancreatic cancer-related proteins, or peptide fragments thereof, in a pancreatic cancer-free population for comparison.Several criteria can be used to determine the inclusion and / or exclusion of a specific individual in the reference population, including the individual's age (e.g., the reference individual may be in the same age range as the individual requiring treatment) and the individual's gender (e.g., the reference individual may be of the same gender as the individual requiring treatment). In certain modalities, the reference is a sample negative for pancreatic cancer or an average of a number of samples. In another example, the concentration levels of reference pancreatic cancer-related proteins or their peptide fragments are derived from patient populations.

[00101] The method described herein further comprises step (d) of identifying the individual as having pancreatic cancer if the levels of Petition 870250095163, dated 10 / 17 / 2025, page 124 / 185 / 61 concentration of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the pancreatic cancer-negative sample(s), or a reference value derived therefrom.In certain embodiments, the identification step (d) occurs after determining that the concentration level of at least one of the pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained differs by about 10% or more, 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more from the concentration level of at least one pancreatic cancer-related reference protein in the pancreatic cancer-negative sample(s) or from a reference value derived from the same.In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins or their peptide fragments in the sample obtained differ by about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more from the concentration levels of the reference pancreatic cancer-related proteins or their fragments from the pancreatic cancer-negative sample(s) or from a reference value derived from the same.

[00102] In certain embodiments, the identification step (d) occurs after determining that the concentration levels of at least apolipoprotein A1 in the sample obtained are lower than the reference apolipoprotein A1 concentration levels of the pancreatic cancer-negative sample(s) or a reference value derived therefrom. In some respects, the concentration level of Petition 870250095163, dated 10 / 17 / 2025, p. 125 / 185 / 61 apolipoprotein A1 of the sample obtained is greater than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the reference apolipoprotein A1 concentration level, obtained or derived from the pancreatic cancer negative sample(s), or a reference value derived therefrom. In some respects, the concentration level of apolipoprotein A1 in the sample obtained is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the reference concentration level of apolipoprotein A1 from the pancreatic cancer-negative sample(s), or a reference value derived therefrom.

[00103] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least apolipoprotein A-II in the sample obtained are decreased relative to the reference apolipoprotein A-II concentration levels of the pancreatic cancer-negative sample(s), or a reference value derived therefrom. In some respects, the concentration level of apolipoprotein A-II in the sample obtained is greater than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the reference apolipoprotein A-II concentration level of the pancreatic cancer-negative sample(s), or a reference value derived therefrom.In some respects, the concentration level of apolipoprotein A-II in the sample obtained is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more, relative to the reference concentration level of apolipoprotein A-II from the pancreatic cancer-negative sample(s), or a reference value derived therefrom.

[00104] In certain modalities, the identification stage (d) occurs Petition 870250095163, dated 10 / 17 / 2025, page 126 / 185 / 61 after determining that the concentration levels of at least the plasma C1 protease inhibitor in the sample obtained are decreased relative to the reference plasma C1 protease inhibitor concentration levels of the pancreatic cancer-negative sample(s), or a reference value derived therefrom. In some respects, the plasma C1 protease inhibitor concentration level in the sample obtained is greater than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more, relative to the reference plasma C1 protease inhibitor concentration level of the pancreatic cancer-negative sample(s) or a reference value derived therefrom.In some respects, the plasma C1 protease inhibitor concentration level of the obtained sample is less than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more, relative to the reference plasma C1 protease inhibitor concentration level of the pancreatic cancer-negative sample(s), or a reference value derived therefrom.

[00105] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least the L-selectin in the sample obtained are lower than the reference L-selectin concentration levels of the pancreatic cancer-negative sample. In some respects, the L-selectin concentration level in the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more, relative to the reference L-selectin concentration level of the pancreatic cancer-negative sample. In some respects, the concentration level of L-selectin in the sample obtained is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more. Petition 870250095163, dated 10 / 17 / 2025, page 127 / 185 / 61 regarding the reference L-selectin concentration level of the sample negative for pancreatic cancer.

[00106] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least tetranectin in the sample obtained are lower than the reference tetranectin concentration levels of the pancreatic cancer-negative sample. In some respects, the tetranectin concentration level of the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more than the reference tetranectin concentration level of the pancreatic cancer-negative sample. In some respects, the tetranectin concentration level of the obtained sample is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the reference tetranectin concentration level of the pancreatic cancer-negative sample.

[00107] In certain embodiments, the identification step (d) occurs after determining that the concentration levels of at least the phospholipid transfer protein in the obtained sample are decreased relative to the concentration levels of the reference phospholipid transfer protein of the pancreatic cancer-negative sample. In some respects, the concentration level of the phospholipid transfer protein in the obtained sample is greater than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the concentration level of the reference phospholipid transfer protein of the pancreatic cancer-negative sample. In some respects, the concentration level of the phospholipid transfer protein in the obtained sample is less than about 20% or more, about 30% or more, about 40% or more, about Petition 870250095163, dated 10 / 17 / 2025, page 128 / 185 / 61 50% or more, approximately 60% or more, or approximately 70% or more relative to the reference phospholipid transfer protein concentration level of the pancreatic cancer-negative sample.

[00108] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least apolipoprotein M in the sample obtained are lower than the reference concentration levels of apolipoprotein M in the pancreatic cancer-negative sample. In some respects, the concentration level of apolipoprotein M in the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the reference concentration level of apolipoprotein M in the pancreatic cancer-negative sample.In some respects, the concentration level of apolipoprotein M in the obtained sample is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the reference concentration level of apolipoprotein M in a sample negative for pancreatic cancer.

[00109] In certain embodiments, the identification step (d) occurs after determining that the concentration levels of at least gelsolin in the sample obtained are lower than the concentration levels of the reference gelsolin in the pancreatic cancer-negative sample. In some respects, the concentration level of gelsolin in the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the concentration level of the reference gelsolin in the pancreatic cancer-negative sample. In some respects, the concentration level of gelsolin in the sample obtained is lower than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to Petition 870250095163, dated 10 / 17 / 2025, page 129 / 185 / 61 reference gelsolin concentration level of the sample negative for pancreatic cancer.

[00110] In certain embodiments, the identification step (d) occurs after determining that the concentration levels of at least the adipocyte plasma membrane-associated protein in the sample obtained are decreased relative to the concentration levels of the reference adipocyte plasma membrane-associated protein from the pancreatic cancer-negative sample. In some respects, the concentration level of the adipocyte plasma membrane-associated protein in the sample obtained is greater than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the concentration level of the reference adipocyte plasma membrane-associated protein from the pancreatic cancer-negative sample.In some respects, the concentration level of adipocyte plasma membrane-associated protein in the obtained sample is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the concentration level of adipocyte plasma membrane-associated protein from the reference sample negative for pancreatic cancer.

[00111] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least the complement factor C1s in the sample obtained are lower than the reference complement factor C1s concentration levels of the pancreatic cancer-negative sample. In some respects, the concentration level of the complement factor C1s in the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more than the reference complement factor C1s concentration level of the pancreatic cancer-negative sample. In some respects, Petition 870250095163, dated 10 / 17 / 2025, page 130 / 185 / 61 the concentration level of complement factor C1s in the sample obtained is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more in relation to the reference concentration level of complement factor C1s in the pancreatic cancer-negative sample.

[00112] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least complement factor C4b in the sample obtained are lower than the reference complement factor C4b concentration levels of the pancreatic cancer-negative sample. In some respects, the concentration level of complement factor C4b in the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more than the reference complement factor C4b concentration level of the pancreatic cancer-negative sample.In some respects, the concentration level of complement factor C4b in the obtained sample is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the reference concentration level of complement factor C4b in the pancreatic cancer-negative sample.

[00113] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least complement factor C6 in the sample obtained are lower than the reference complement factor C6 concentration levels of the pancreatic cancer-negative sample. In some respects, the concentration level of complement factor C6 in the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the reference complement factor C6 concentration level of the Petition 870250095163, dated 10 / 17 / 2025, page 131 / 185 / 61 negative sample for pancreatic cancer. In some aspects, the concentration level of complement factor C6 in the sample obtained is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more in relation to the reference concentration level of complement factor C6 of the sample negative for pancreatic cancer.

[00114] In certain embodiments, the identification step (d) occurs after it has been determined that the concentration levels of at least fibronectin in the sample obtained are lower than the reference fibronectin concentration levels of the pancreatic cancer-negative sample. In some respects, the fibronectin concentration level of the sample obtained is higher than about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more than the reference fibronectin concentration level of the pancreatic cancer-negative sample. In some respects, the fibronectin concentration level of the obtained sample is less than approximately 20% or more, approximately 30% or more, approximately 40% or more, approximately 50% or more, approximately 60% or more, or approximately 70% or more relative to the reference fibronectin concentration level of the pancreatic cancer-negative sample.

[00115] The method described herein further comprises step (e) of treating the individual thus identified as having pancreatic cancer with a pancreatic cancer treatment regimen.

[00116] In certain embodiments of any of the methods described herein, comparing the concentration level of at least one pancreatic cancer-related protein in the obtained sample, or a value derived therefrom, with the reference concentration level of the pancreatic cancer-related protein in the pancreatic cancer-negative sample involves using multivariate statistical analysis. In one embodiment, the Petition 870250095163, dated 10 / 17 / 2025, page 132 / 185 / 61 Multivariate statistical analysis is selected from principal component analysis (“PCA”), or partial least squares designs for latent structure discriminant analysis (“PLS-DA”). In certain embodiments, a computer is used for statistical analysis. Data for statistical analysis can be extracted from chromatograms (i.e., mass signal spectra) using software for statistical methods known in the art.

[00117] In some respects, the present description relates to a method for monitoring pancreatic cancer progression and treating pancreatic cancer in an individual. In one embodiment, the method includes quantifying pancreatic cancer-related proteins, or peptide fragments thereof, at one or more time points after treatment initiation to monitor pancreatic cancer progression or regression in an individual. Consequently, the method comprises: (a) providing an initial biological sample obtained from the individual at an initial time point;(b) to evaluate a first pancreatic cancer-related proteomic profile by measuring the concentration levels of at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the first sample obtained; (c) to compare the first pancreatic cancer-related proteomic profile with a reference pancreatic cancer-related proteomic profile from a pancreatic cancer-negative sample;(d) to determine that there is a first difference between the first proteomic profile related to cancer of; Petition 870250095163, dated 10 / 17 / 2025, page 133 / 185 / 61 pancreas and the reference proteomic profile related to pancreatic cancer from the sample negative for pancreatic cancer, the first difference being indicative of pancreatic cancer; (e) provide a second biological sample obtained from the individual at the second time point, which is after the first time point; (f) evaluate a second proteomic profile related to pancreatic cancer by measuring the concentration levels of proteins related to pancreatic cancer, or peptide fragments thereof, from the second sample obtained; (g) compare the second proteomic profile related to pancreatic cancer with the reference proteomic profile related to pancreatic cancer from the sample negative for pancreatic cancer;(h) determine that there is a second difference between the first pancreatic cancer-related proteomic profile and the reference pancreatic cancer-related proteomic profile of the pancreatic cancer-negative sample, the second difference being indicative of pancreatic cancer; (i) determine pancreatic cancer progression or regression based at least in part on the first and second differences; and (j) treat the individual as indicated with a pancreatic cancer treatment regimen.

[00118] In certain embodiments of the previous method, the period between the first and second administration is at least 1 month, at least 2 months, at least 3 months, at least 6 months, at least 9 months, or at least 12 months, preferably at least 3 months. In some embodiments, the treatment was administered to the individual before obtaining the first two biological samples. In other embodiments, the treatment was administered to the individual in the interval(s) between the collection of biological samples. In certain embodiments, the first biological sample, the second biological sample, or both, are blood or urine, preferably serum, plasma, or urine.

[00119] The present description also provides a method for Petition 870250095163, dated 10 / 17 / 2025, page 134 / 185 / 61 to diagnose and treat pancreatic cancer in an individual. The method comprises: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins or protein fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin;(c) compare the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or fragments thereof, in a pancreatic cancer-negative sample; (d) identify the individual as having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or fragments thereof, in a pancreatic cancer-negative sample; and (e) treat the individual thus identified with a pancreatic cancer treatment regimen.

[00120] The present description also provides a method for diagnosing and treating pancreatic cancer in an individual comprising: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins, or fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, Petition 870250095163, dated 10 / 17 / 2025, pages 135 / 185 45 / 61 tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cls, complement factor C4b, complement factor C6, and fibronectin from the obtained sample; (c) compare the concentration levels of pancreatic cancer-related proteins, or fragments thereof, from the obtained sample with the reference concentration levels of pancreatic cancer-related proteins, or fragments thereof, from a pancreatic cancer-negative or baseline sample;(d) measure the concentration levels of at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins, or fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor Cl1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cl1, complement factor C4b, complement factor C6, and fibronectin; (e) compare the concentration levels of pancreatic cancer-related proteins, or fragments thereof, from the obtained sample with the reference concentration levels of pancreatic cancer-related proteins, or fragments thereof, from a pancreatic cancer-negative sample or baseline;(f) identify the individual as having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or fragments thereof, in the sample obtained are different from the concentration levels of reference pancreatic cancer-related proteins, or fragments thereof, in the pancreatic cancer-negative sample, and the concentration levels of pancreatic cancer-related proteins, or fragments thereof, in the sample obtained are different from the concentration levels of reference pancreatic cancer-related proteins, or fragments thereof; Petition 870250095163, dated 10 / 17 / 2025, page 136 / 185 / 61 same, from the negative sample for pancreatic cancer or baseline; and (g) treat the individual thus identified with a pancreatic cancer treatment regimen.

[00121] In certain embodiments of the previous method, the identification step (f) occurs after it has been determined that the concentration levels of at least one, at least two, at least three, at least four, at least five, at least six or at least seven of the pancreatic cancer-related proteins, or fragments thereof, in the sample obtained differ by about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more or about 70% or more from the concentration levels of the reference pancreatic cancer-related proteins, or fragments thereof, in the pancreatic cancer-negative or baseline sample. Methods for quantifying proteins related to pancreatic cancer or peptide fragments thereof.

[00122] In one embodiment, pancreatic cancer-related proteins, or peptide fragments thereof, are measured by a spectroscopic technique, the spectroscopic technique being selected from the group consisting of liquid chromatography, gas chromatography, liquid chromatography mass spectrometry, gas chromatography mass spectrometry, high-performance liquid chromatography mass spectrometry, capillary electrophoresis mass spectrometry, nuclear magnetic resonance (NMR) spectrometry, Raman spectrometry and infrared spectrometry.

[00123] In certain embodiments, the measurement of concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, may be performed by a method comprising mass spectrometry including, but not limited to, gas chromatography-mass spectrometry (GC-MS) and GC mass spectrometry. Petition 870250095163, dated 10 / 17 / 2025, page 137 / 185 / 61 by liquid chromatography (e.g., LC-MS, LC-MS-MS, LC-MRM, LCSIM, and LC-SRM). In certain embodiments, mass spectrometry is a multiple-reaction monitoring mass spectrometry, a parallel-reaction monitoring mass spectrometry, a matrix-assisted laser desorption / ionization (MALDI) mass spectrometry, or a data-independent acquisition mass spectrometry. In yet another embodiment, multiple-reaction monitoring mass spectrometry is a multiple immunological reaction monitoring mass spectrometry, a parallel immunological reaction monitoring mass spectrometry, or a data-independent acquisition immunological mass spectrometry.

[00124] In one embodiment, the procedure comprising mass spectrometry involves introducing a protein sample into a mass spectrometry unit, which is subsequently fragmented within the mass spectrometry unit, and the masses of the fragments are recorded and provided for analysis.

[00125] In some embodiments, the mass spectrometry process for determining whether pancreas-related proteins are elevated comprises enzymatic or chemical digestion of proteins, or peptide fragments thereof, from a sample obtained from an individual into peptide fragments. The peptide fragments are optionally separated and / or ionized and captured by mass spectrometry. The digestion may comprise a proteolytic digestion involving the treatment of a preparation comprising pancreatic cancer-related proteins with an acid, a base, or an enzyme, such as trypsin or another proteolytic enzyme. One embodiment comprises a shotgun proteomic quantification in which all proteins in a complex mixture, such as serum, urine, and cell lysates, are hydrolyzed or cleaved into peptides and followed by multidimensional HPLC-MS, which aims to generate a Petition 870250095163, dated 10 / 17 / 2025, pp. 138 / 185 48 / 61 global profile of protein mixtures as a “shotgun” genome sequencing.

[00126] Thus, according to one aspect of the description, a method is provided for determining whether pancreas-related proteins, or peptide fragments thereof, are elevated in a sample obtained from an individual, the pancreas-related proteins, or peptide fragments thereof, being selected from at least one of the pancreatic cancer-related proteins, or peptide fragments thereof, comprising apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C11, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C11, complement factor C4b, complement factor C6 and fibronectin, the method comprising enzymatic or chemical digestion of the proteins, or peptide fragments thereof, from the sample obtained from an individual into peptide fragments to produce peptide fragments thereof;Introduction of a solution comprising the peptide fragments into a mass spectrometer, optionally after one or more treatments comprising liquid chromatography or other treatments, to quantify the peptide fragments; determine the concentration of peptide fragment(s) relative to a baseline, such as a standard(s) (e.g., peptide standards); and assess whether the fragment(s) is / are elevated relative to the baseline or standard(s); identify the individual as having pancreatic cancer or predisposed to developing it if one or more of the peptides are elevated relative to the baseline or standard; and treat or induce treatment of the individual with a treatment for pancreatic cancer, optionally comprising a chemotherapeutic agent approved for use in the treatment of pancreatic cancer.

[00127] Proteins, or peptide fragments thereof, can be Petition 870250095163, dated 10 / 17 / 2025, pp. 139 / 185 49 / 61 fragmented within the mass spectrometry unit and the masses of the fragments recorded and provided for analysis.

[00128] The baseline is a normal level of a protein or peptide derived from an individual or a population of individuals who do not have pancreatic cancer. The standard may comprise one or more proteins related to pancreatic cancer, or peptide fragments thereof, at concentrations that correspond to such normal levels. The standard may be a value derived from a sample or samples previously obtained from individuals without pancreatic cancer. The standard may comprise one or more of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C11, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C11, complement factor C4b, complement factor C6, and fibronectin, or fragments thereof.

[00129] In another embodiment, a plurality of patterns is provided comprising one or more of the peptide fragments related to pancreatic cancer, in concentrations corresponding to normal levels. The patterns may comprise any combination of peptide fragments derived from apolipoprotein A1, apolipoprotein AII, plasma protease inhibitor Cl1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cl1, complement factor C4b, complement factor C6, and fibronectin. Treatment of pancreatic cancer

[00130] Before treatment for pancreatic cancer, the individual will typically undergo a biopsy to confirm the presence of pancreatic cancer. The biopsy may be selected from percutaneous biopsy, endoscopic biopsy, or surgical biopsy. A percutaneous biopsy involves inserting a hollow needle through the skin into the pancreas to... Petition 870250095163, dated 10 / 17 / 2025, page 140 / 185 / 61 remove a sample of the tumor. The procedure can be facilitated by imaging tests, such as ultrasound or computed tomography. An endoscopic biopsy involves passing an endoscope into the pancreas through the throat and small intestine. Samples are obtained from the bile or pancreatic ducts using endoscopic ultrasound to introduce a needle into the tumor or a brush to remove cells from the bile or pancreatic ducts. A surgical biopsy may be performed if it is desirable to determine if the pancreatic cancer has spread. A surgical biopsy can be performed laparoscopically (laparoscopic surgery). Optionally, additional tests are performed to assess whether the cancer cells obtained in the biopsy have mutations in certain genes. If mutations are found in genes implicated in pancreatic cancer, targeted therapy may be part of the pancreatic treatment regimen.Data from the proteomic profile assessment can be used in conjunction with this information.

[00131] Imaging tests can be performed to facilitate diagnosis. Imaging tests may use X-rays, magnetic fields, sound waves, or radioactive substances to visualize a tumor. Examples of imaging tests include computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, cholangiopancreatography (CPAN), such as magnetic resonance cholangiopancreatography or percutaneous transhepatic cholangiography (PTC), positron emission tomography (PET), or angiography.

[00132] The pancreatic treatment regimen may include surgery to remove a tumor.

[00133] The treatment regimen for pancreatic cancer may alternatively or additionally include one or more therapeutic agents to treat pancreatic cancer. Examples of such therapeutic agents include the following: Abraxane (Albumin-Stabilized Nanoparticle Formulation of Paclitaxel); Afinitor (Everolimus); Capecitabine; Hydrochloride of Petition 870250095163, dated 10 / 17 / 2025, pp. 141 / 185 51 / 61 erlotinib; Everolimus; 5-FU (Fluorouracil Injection); Fluorouracil; Gemcitabine, MRTX1133, which targets Kras G12D mutants, and / or Olaparib. Treatment of pancreatic cancer may additionally or alternatively include radiotherapy to reduce tumor size.

[00134] In one embodiment, one or more therapeutic agents are formulated in a delivery vehicle, such as a lipid nanoparticle. The therapeutic agents formulated in a delivery vehicle, such as a lipid nanoparticle, may include one or more RNA sequences of the aforementioned pancreatic cancer biomarkers, or RNA sequences of biomarkers associated with the aforementioned pancreatic biomarkers, which may be used to suppress their action in the disease or reduce their levels. Kits

[00135] The proteomic profile described herein can be used in tests, assays, methods, and kits to diagnose, predict, modulate, or monitor pancreatic cancer, including ongoing assessment, monitoring, and / or susceptibility evaluation. This description includes a kit for diagnosing pancreatic cancer by measuring and identifying at least one or more pancreatic cancer-related proteins, or fragments thereof, associated with pancreatic cancer.Consequently, the kit may comprise (a) a detector configured to detect concentration levels of at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins, or fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C11, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C11s, complement factor C4b, complement factor C6e. Petition 870250095163, dated 10 / 17 / 2025, page 142 / 185 / 61 fibronectin at control levels corresponding to a control group of individuals negative for pancreatic cancer, (c) a multivariate analysis system configured to analyze a difference in the concentration levels of pancreatic cancer-related proteins, or fragments thereof, and control levels, and (d) optionally, instructions for a pancreatic cancer diagnostic method, wherein the method comprises measuring, using the detector, the levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the biological sample obtained, and comparing the levels of pancreatic cancer-related proteins obtained, or peptides thereof, with control levels of pancreatic cancer-related proteins, or peptides thereof, obtained from individuals negative for pancreatic cancer.In one embodiment, the pancreatic cancer diagnostic method comprises a multimetabolite detector configured to measure the levels of proteins or peptides related to pancreatic cancer. The detector may be part of a mass spectrometry unit, optionally communicating operationally with a chromatography unit, such as a liquid chromatography unit.

[00136] In some respects, the kit may be for measuring pancreatic cancer-related proteins or fragments by a physical separation technique (as described above). In some respects, the kit may be for measuring pancreatic cancer-related proteins or peptides by a methodology other than a physical separation method such as, for non-limiting example, a colorimetric, enzymatic, and immunological methodology. The kit may also include one or more appropriate negative and / or positive controls. The kit described herein may include other reagents, such as buffers and solutions for performing the tests. Computer-implemented method Petition 870250095163, dated 10 / 17 / 2025, pp. 143 / 185 53 / 61

[00137] The description also refers to a computer-implemented method for processing a biological sample from an individual, diagnosing and treating pancreatic cancer. The computer-implemented method may additionally allow monitoring of pancreatic cancer progression across multiple time points to support a more effective treatment regimen.

[00138] The computer-implemented method comprises receiving a biological sample from the individual; processing the sample in a spectroscopy unit connected directly or wirelessly, or may utilize any suitable communication technology, to a processing device, the processing device having memory to store measurement data from the spectroscopy unit; and, in the spectroscopy unit, measuring the levels of at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins, fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor Cl1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor Cl1, complement factor C4b,The processing device comprises one or more data storage devices that can be configured or adapted to store method-related data. For example, the data storage device can be configured or adapted to store measurement data from the spectroscopy unit. The data storage device may also comprise computer program code stored therein. The program code in this embodiment may include program code to, at least, execute the steps of the method aspect after execution of the method. Petition 870250095163, dated 10 / 17 / 2025, pp. 144 / 185 / 61

[00139] The computer-implemented method further comprises comparing the stored measurement data with a value in memory representing a negative sample for pancreatic cancer, using multivariate statistical analysis; storing, in the processing device, a result that corresponds to at least one, at least two, at least three, at least four, at least five, at least six, or at least seven pancreatic cancer-related proteins, or fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the obtained sample,where the result identifies the individual as having pancreatic cancer if the measurement data representing the level of the pancreatic cancer-related protein, or a fragment thereof, differs from a reference concentration value of a pancreatic cancer-related protein, or a fragment thereof, from a pancreatic cancer-negative sample; and display the result or a pancreatic cancer treatment regimen on an electronic display connected directly or wirelessly to the processor for the individual identified as having pancreatic cancer, or as having a predisposition to developing pancreatic cancer.

[00140] The displayed result or treatment regimen comprises electronic text, optionally with graphic icons. Optionally, the graphic icons are part of an electronic control panel that displays the result in a format that simplifies the result and / or provides a treatment recommendation based on the result.

[00141] As observed, the computer-implemented method may additionally allow for protein monitoring. Petition 870250095163, dated 10 / 17 / 2025, pp. 145 / 185 / 61 related to pancreatic cancer at multiple time points to aid a more effective treatment regimen. A non-limiting example of such a process is described in Figure 1. The method comprises obtaining a biological sample (e.g., serum sample) at time point 1 (T1). The sample is subjected to proteolysis 10A to produce hydrolyzed proteins, the hydrolyzed proteins are subjected to mass spectrometry 20A, and the pancreatic cancer-related proteins are measured 30A. The concentrations are compared to a pancreatic cancer-negative sample 40A, and it is determined whether the concentration(s) of the protein(s) are increased or decreased relative to the standard 50A. In this non-limiting example, the proteins associated with pancreatic cancer are at least one of L-selectin, tetranectin, phospholipid transfer protein, and / or fibronectin.In one example of the description, at least one of L-selectin, tetranectin, and / or phospholipid transfer protein is elevated relative to a baseline (e.g., negative pancreatic sample). In this case, the individual is identified as having a possible risk of having pancreatic cancer or developing the disease (YES). If the concentrations of L-selectin, tetranectin, phospholipid transfer protein, and / or fibronectin do not differ significantly from the baseline, the individual is identified as having a low risk of pancreatic cancer (NO). It is understood that the greater the magnitude of the elevation between the measured pancreatic cancer-related proteins and the pancreatic cancer-related proteins of the negative pancreatic sample, the worse the likelihood of the individual having pancreatic cancer or developing the disease.It is desirable that this information be obtained earlier in the individual's life (for example, 40 years or younger, 35 years or younger, 30 years or younger, or 25 years or younger) in order to increase any benefits of delaying or offsetting the progression of pancreatic cancer. Petition 870250095163, dated 10 / 17 / 2025, pp. 146 / 185 / 61

[00142] In other modalities, although a smaller magnitude of elevation between measured pancreatic cancer-related proteins and pancreatic cancer-related proteins from the negative pancreatic sample reflects the low probability of the individual having or developing pancreatic cancer up to that point, there is no guarantee that the magnitude of the elevation will remain small at a later time. Therefore, it is advisable that these individuals continuously monitor their risk of having or developing pancreatic cancer regularly. For example, if the individual is identified as having a possible risk of having pancreatic cancer or developing the disease (SIM), a second biological sample (e.g., serum sample) is obtained at time 2 (T2), which is after T1.In some methods, the individual's risk of having or developing pancreatic cancer is measured over the individual's lifetime (or at least over a prolonged period, such as at least two months, at least four months, at least six months, at least one year, at least two years, at least five years, at least one decade, at least two decades, or at least three decades). The sample is subjected to proteolysis 10B to produce hydrolyzed proteins, the hydrolyzed proteins are subjected to mass spectrometry 20B, and the proteins related to pancreatic cancer are measured 30B. The concentrations are compared with T2 40B, and it is determined whether the protein(s) is / are increased or decreased relative to the T2 concentration levels 50B.If at least one of the pancreatic cancer-related proteins selected from L-selectin, tetranectin, phospholipid transfer protein, and / or fibronectin is elevated relative to T1 by a cutoff value (e.g., at least 10%, at least 20%, at least 30%), then the individual is identified as having a high risk of having pancreatic cancer or developing the disease (SIM). The individual is typically identified as having pancreatic cancer after a biopsy and analysis of the results. Petition 870250095163, dated 10 / 17 / 2025, page 147 / 185 / 61 presence of cancerous cells (e.g., using microscopy). If the concentrations of L-selectin, tetranectin, phospholipid transfer protein, and / or fibronectin do not differ significantly from T1, then the individual is identified as having a low risk of pancreatic cancer 60 (NO). Pancreatic cancer-related proteins can be measured at a third time point, time point 3 (T3), which is after T2, if necessary. The concentrations of pancreatic cancer-related proteins at T3 can be compared to levels at one or both T2 and T1 levels to identify whether the individual has a high or low risk of developing pancreatic cancer or the disease.As a result, the method described herein allows for monitoring changes in the state of pancreatic cancer or the risk of developing (or re-developing) pancreatic cancer over time, particularly after any treatment regimen. The treatment regimen typically involves surgery, but may additionally or alternatively include the administration of chemotherapeutic agents and / or radiotherapy.

[00143] The following examples describe some exemplary ways of practicing certain methods described herein. It should be understood that the examples are for illustrative purposes only and are not intended to limit the scope of the systems and methods described herein. EXAMPLES Example 1: Diagnosis and treatment of a patient with stage one pancreatic cancer, as determined by monitoring changes in pancreas-related protein concentrations over time.

[00144] A patient's proteomic profile was monitored over three years, from 2019 to 2022, as part of a multiomics health assessment provided by the Applicant. Each of the proteins presented below in Table 1 was identified as exhibiting a significant alteration. Petition 870250095163, dated 10 / 17 / 2025, pp. 148 / 185 / 61 in blood concentration (nM), measured over a three-year period. Surprisingly, certain proteins (L-selectin, tetranectin, and phospholipid transfer protein) also showed significant increases in concentration at time point 2 (T2) compared to time point 1 (T1). On the other hand, fibronectin decreased by 323.98% from time point 3 (T3) to time point 2 (T2). Table 1: Changes in the concentration of proteins related to pancreatic cancer over time_______________________________ Protein Concentration in Blood Change Normal Range (nM) T1: Time Point 1 (2019) (nM) T2: Time Point 2 (2021) (nM) T3: Time Point 3 (2022) (nM) Increase / Decrease T3 vs T1* % change (T3 vs T1) % change (T2 vs T1) Apolipoprotein AI 26,655.0 -68,642.5 60,300.0 66,386.0 81,325.0 Increased 34.87 10.09 Apolipoprotein AII 5,400.5 -15,664.9 13,200.0 12,699.0 15,733.0 Increased 19.19 -3.08 Plasma C1 protease inhibitor 963.9- 2161.2 1910.0 1945.7 2279.7 Increased 19.36 1.87 L-selectin 21.97 0.1 64.3 76.8 91.0 Increased 41.52 19.44 Tetranectin 119.8- 307.1 204.0 309.0 334.8 Increased 64.12 51.47 Phospholipid transfer protein 26.97 2.0 60.6 72.0 78.1 Increased 28.88 18.81 Apolipoprotein M 149.4- 691.5 622.0 635.9 754.0 Increased 21.22 2.23 Complement C1r 249.5- 495.9 447.0 422.4 489.4 Increased 9.49 -5.50 Complement C1s 168.7- 340.6 279.0 296.4 341.2 Increased 22.29 6.24 Alpha chain of binding protein C4b 1,418.4- 5,184.5 4.970.0 N / A 5,321.2 Increased 7.07 N / A Complement C6 99.6- 355.1 227.0 287.5 344.1 Increased 51.59 26.65 Gelsolin 253.1560.0 442.0 460.3 553.2 Increased 25.16 4.14. Petition 870250095163, dated 10 / 17 / 2025, pp. 149 / 185 / 61 Protein Concentration in Blood Change Normal Range (nM) T1: Time Point 1 (2019) (nM) T2: Time Point 2 (2021) (nM) T3: Time Point 3 (2022) (nM) Increase / Decrease T3 vs T1* % change (T3 vs T1) % change (T2 vs T1) Adipocyte plasma membrane-associated protein 7.6-33.3 21.3 24.2 34.6 Increased 62.44 13.62 Fibronectin 219.0- 2,636.2 242.0 1,254.2 295.7 *Decrease from T2 to T3 -323.98 418.26 *Change in fibronectin percentage was between T3 and T2

[00145] L-selectin, tetranectin, and phospholipid transfer protein were elevated at T2 (time 2) and were therefore identified as early indicators of pancreatic cancer. The concentrations of each of these proteins were also elevated at T3 (time 3). In addition, fibronectin levels were low at times T1 (242.0 nM) and T3 (295.7 nM), but elevated at T2 (1254.2 nM). A change of -323.98% in fibronectin was observed between T2 and T3.

[00146] The results are surprising, given that tetranectin levels have been shown to be decreased in pancreatic cancer in previous studies (Caputo et al., 2022, Cancers (Basel), 14(19):4658; and Felix et al., 2013, PloS ONE, 8e82755). However, the inventors found that this protein increased over the measurement period.

[00147] The patient was evaluated by a physician and diagnosed with stage 1 pancreatic cancer. A biopsy was obtained from the patient and examined by microscopy to confirm the diagnosis. The patient underwent surgery for tumor removal. To our knowledge, this is the first positive early-stage diagnosis and treatment of pancreatic cancer using the novel proteomic profile identified here.

[00148] Changes in blood concentrations of one or a combination of certain proteins associated with pancreatic cancer, measured over time, provide a tool for early detection of Petition 870250095163, dated 10 / 17 / 2025, pp. 150 / 185 / 61 pancreatic cancer that was not otherwise available using known diagnostic approaches. Monitoring the combination of proteins identified as elevated in the patient to diagnose and treat pancreatic cancer therefore represents a significant advance in technique.

[00149] Other examples of implementations will become evident in light of the teachings of the present description.

[00150] Note that titles or subtitles may be used throughout the present description for the reader's convenience, but in no way should they limit the scope of the invention. Furthermore, certain theories may be proposed and described herein; however, in no way should such theories limit the scope of the invention.

[00151] Elements of the methods and / or systems of the description described in connection with the examples apply mutatis mutandis to other aspects of the description. Therefore, it should be understood that the methods and / or systems of the present description encompass any methods and / or systems comprising any of the steps and / or components mentioned herein, in any embodiment in which each step or component is present independently, as defined herein. Many such methods and / or systems, in addition to those specifically defined herein, may be included.

[00152] The dimensions and values ​​described herein should not be understood as strictly limited to the exact numerical values ​​quoted. Instead, unless otherwise specified, each of these dimensions is intended to mean both the stated value and a functionally equivalent range around that value. For example, a dimension described as “40 mm” is intended to mean “approximately 40 mm”.

[00153] All documents cited herein, including any patent or application cross-referenced or related and any patent or patent application for which this application claims priority or benefit, Petition 870250095163, dated 10 / 17 / 2025, pp. 151 / 185 / 61 ​​are incorporated herein by reference in their entirety, unless expressly excluded or otherwise limited. Citation of any document does not constitute an admission that it is an earlier technique in relation to any description described or claimed herein, or that, alone or in any combination with any other reference or references, it teaches, suggests, or describes such description. Furthermore, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition ascribed to that term in this document shall prevail.

[00154] Although particular embodiments of the present description have been illustrated and described, it would be obvious to those skilled in the art that various other alterations and modifications could be made without departing from the scope of the present description. Therefore, the appended claims intend to cover all alterations and modifications that are within the scope of this description.

Claims

1. A method for treating pancreatic cancer in an individual, characterized in that the method comprises: (i) obtaining a proteomic profile from an individual, the proteomic profile having been previously obtained by: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of one or a combination of at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the sample obtained;(c) comparing the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of a negative pancreatic cancer reference value and / or of a sample obtained at a previous point in time from the individual; (ii) identifying the individual as being at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of a negative pancreatic cancer reference value and / or of a sample obtained at a previous point in time from the individual;(iii) optionally obtain a biopsy of the individual thus identified as being at risk of having pancreatic cancer in step (ii); (iv) analyze the biopsy to determine if cancerous cells are present; (v) identify the individual as having pancreatic cancer if the individual is identified as being at risk of having pancreatic cancer based on the proteomic profile in step (ii) and if cancerous cells are present in the biopsy; and (vi) optionally remove the cancerous tissue from the pancreas and / or bile duct(s) of the individual if the individual is identified as having pancreatic cancer.

2. A method for diagnosing and treating pancreatic cancer in an individual, characterized in that the method comprises: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of one or a combination of at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the sample obtained;(c) compare the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of a negative pancreatic cancer reference value and / or of a sample obtained at an earlier point in time from the individual; (d) identify the individual as having pancreatic cancer or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of a negative pancreatic cancer reference value and / or of a sample obtained at an earlier point in time from the individual;and (e) optionally, treat or cause the treatment of the individual so identified as having pancreatic cancer with a pancreatic cancer treatment regimen, optionally comprising surgery and / or administration of a chemotherapeutic agent or radiotherapy.

3. A method for diagnosing and treating pancreatic cancer in an individual, characterized in that the method comprises: (a) providing a biological sample obtained from the individual; (b) measuring or having measured in a spectroscopy unit the concentration levels of a combination of pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1; apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6 and fibronectin from the sample obtained;(c) compare or have compared concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, as determined in the spectroscopy unit with reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a negative reference value for pancreatic cancer and / or from a sample obtained at a point in time prior to the individual's death;(d) identify the individual as having pancreatic cancer or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the pancreatic cancer-negative sample and / or a sample obtained at an earlier point in time from the individual; and (e) optionally, treat or cause the treatment of the individual thus identified as having pancreatic cancer with a pancreatic cancer treatment regimen, optionally comprising surgery and / or administration of a chemotherapeutic agent or radiotherapy.

4. A method according to any one of claims 1 to 3, characterized in that the treatment of pancreatic cancer comprises reducing blood levels of one or more of the proteins related to pancreatic cancer, or peptide fragments thereof, in an individual diagnosed as having pancreatic cancer.

5. A method according to claim 4, characterized in that the adjustment of blood levels of one or more pancreatic cancer-related proteins, or peptide fragments thereof, in the individual occurs until the pancreatic cancer-related proteins, or peptide fragments thereof, are reduced to a predetermined level in the individual.

6. Method according to any one of claims 1 to 5, characterized in that the identification step occurs after determining that the concentration levels of at least one, at least two, at least three, at least four, or at least five of the pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are elevated by about 10% or more, 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the concentration levels of the reference pancreatic cancer-related proteins, or peptide fragments thereof, of the negative reference value for pancreatic cancer and / or relative to the concentration levels in a sample previously obtained from the individual.

7. A method according to any one of claims 1 to 6, characterized in that measuring the concentration levels of pancreatic cancer-related proteins or peptide fragments comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

8. Method according to any one of claims 1 to 7, characterized in that the concentration level of at least tetranectin is measured.

9. A method according to any one of claims 1 to 8, characterized in that the sample obtained is blood or urine.

10. Method according to any one of claims 1 to 8, characterized in that the sample obtained is serum or plasma.

11. Method according to claim 9, characterized in that the sample obtained is urine.

12. A method according to any one of claims 1 to 8, characterized in that pancreatic cancer-related proteins, or peptide fragments thereof, are measured by a spectroscopic technique, wherein the spectroscopic technique is selected from the group consisting of liquid chromatography, gas chromatography, liquid chromatography mass spectrometry, gas chromatography mass spectrometry, high-performance liquid chromatography mass spectrometry, capillary electrophoresis mass spectrometry, nuclear magnetic resonance (NMR) spectrometry, Raman spectrometry and infrared spectrometry.

13. Method according to claim 12, characterized in that the spectroscopic technique comprises mass spectrometry.

14. A method according to any one of claims 1 to 8, characterized in that the comparison of the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of the obtained sample with the concentration levels of reference values ​​comprises using multivariate statistical analysis.

15. Method according to claim 14, characterized in that the multivariate statistical analysis is selected from principal component analysis (PCA), or partial least squares designs for latent structure discriminant analysis (PLS-DA).

16. Method for monitoring protein or peptide fragments in an individual and treating pancreatic cancer in an individual, characterized in that the method comprises: (a) providing a first biological sample obtained from the individual at a first point in time; (b) evaluating a first proteomic profile related to pancreatic cancer by measuring the concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1;apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin from the first biological sample; (c) compare the first pancreatic cancer-related proteomic profile with a reference pancreatic cancer-related proteomic profile from a pancreatic cancer-negative sample; (d) determine that there is a first difference between the first pancreatic cancer-related proteomic profile and the reference pancreatic cancer-related proteomic profile from the pancreatic cancer-negative sample, the first difference being indicative of pancreatic cancer;(e) provide a second biological sample obtained from the individual at a second point in time that is after the first point in time; (f) evaluate a second proteomic profile related to pancreatic cancer by measuring the concentration levels of proteins related to pancreatic cancer, or peptide fragments thereof, from the second biological sample; (g) compare the second proteomic profile related to pancreatic cancer with the reference proteomic profile related to pancreatic cancer from the pancreatic cancer-negative sample; (h) determine that there is a second difference between the first proteomic profile related to pancreatic cancer and the reference proteomic profile related to pancreatic cancer from the pancreatic cancer-negative sample, the second difference being indicative of pancreatic cancer; (i) determine pancreatic cancer progression or a risk of having pancreatic cancer based, at least in part, on the first and second differences;and (j) optionally, treat or cause the treatment of the individual if identified as having pancreatic cancer with a pancreatic cancer treatment regimen, optionally comprising surgery and / or administration of an anticancer therapeutic agent or radiotherapy.

17. Method according to claim 16, characterized in that the time period between the first and second points in time is at least 1 month, at least 2 months, at least 3 months, or at least 6 months.

18. Method according to claim 16 or 17, characterized in that measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the first and / or second biological samples comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

19. Method according to any one of claims 16 to 18, characterized in that the concentration level of at least tetranectin is measured.

20. Method according to claim 17, characterized in that the first sample, the second sample, or both are blood or urine, or in that both samples are the same type of specimen and are selected from serum, plasma, or urine.

21. Pancreatic cancer diagnostic kit, characterized in that it comprises: (a) a detector configured to detect concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1; apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin obtained from a biological sample; (b) a composition comprising apolipoprotein A1;apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin at control levels corresponding to a control group of individuals negative for pancreatic cancer;(c) a multivariate analysis system configured to analyze a difference in the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, and control levels, and (d) optionally, providing instructions for a pancreatic cancer diagnostic method, wherein the method comprises measuring, using the detector, the levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the biological sample obtained, and comparing the levels of pancreatic cancer-related proteins obtained, or peptide fragments thereof, with control levels of pancreatic cancer-related proteins, or peptide fragments thereof, obtained from individuals negative for pancreatic cancer and / or from a sample obtained at a previous point in time from the individual.

22. Kit according to claim 21, characterized in that the detector comprises a multiproteomic detector configured to measure the levels of pancreatic cancer-related proteins, or peptide fragments thereof, comprising apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6 and fibronectin.

23. Kit according to claim 21 or 22, characterized in that the detector is configured to measure the concentration levels of pancreatic cancer-related proteins or peptide fragments comprising at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

24. Kit according to claim 23, characterized in that the detector is configured to measure at least tetranectin.

25. A computer-implemented method for processing a biological sample from an individual, diagnosing pancreatic cancer, and treating pancreatic cancer, characterized in that the computer-implemented method comprises: (a) receiving a biological sample obtained from the individual; (b) processing the sample in a spectroscopy unit connected directly or wirelessly to a processing device, the processing device having memory to store measurement data from the spectroscopy unit; (c) in the spectroscopy unit, measuring the levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein,complement factor C1s, complement factor C4b or complement factor C6 and fibronectin and store the measurement data in the processor; (d) compare the stored measurement data with a reference value in memory that represents a negative sample for pancreatic cancer, using, optionally, multivariate statistical analysis; (e) store, in the processing device, a result that corresponds to at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from the group consisting of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s,complement factor C4b or complement factor C6 and fibronectin from the sample obtained, wherein the result identifies the individual as having pancreatic cancer or at risk of having pancreatic cancer if the measurement data representing the levels of pancreatic cancer-related proteins, or peptide fragments thereof, are different from reference pancreatic cancer-related protein concentration levels, or peptide fragments thereof, from a pancreatic cancer-negative sample; (f) display the result on an electronic display connected directly or wirelessly to the processor for the individual identified as having pancreatic cancer, at risk of having pancreatic cancer, or as having a predisposition to developing pancreatic cancer; and (g) optionally, treat or cause treatment of the individual identified as having pancreatic cancer with a pancreatic cancer regimen.optionally including surgery and / or administration of an anticancer therapeutic agent or radiotherapy.

26. Method according to claim 25, characterized in that the displayed result is included in a user interface that is a control panel.

27. Method according to claim 25 or 26, characterized in that the displayed result is part of the multimedia information displayed in the user interface.

28. A method according to any one of claims 25 to 27, characterized in that the spectroscopy unit comprises a detector or is operationally connected to a detector that is configured to measure the concentration levels of pancreatic cancer-related proteins or peptide fragments, optionally configured to measure at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

29. Method according to claim 28, characterized in that the detector is configured to measure at least tetranectin.

30. A method for diagnosing and treating pancreatic cancer in an individual, characterized in that the method comprises: (a) providing a biological sample obtained from the individual; (b) measuring the concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, or complement factor C6, and fibronectin;(c) compare the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a pancreatic cancer-negative sample and / or a sample obtained at an earlier point in time from the individual; (d) identify the individual as having pancreatic cancer or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a pancreatic cancer-negative sample and / or a sample obtained at an earlier point in time from the individual;and (e) optionally, treat or cause the treatment of the individual so identified with a pancreatic cancer treatment regimen or radiotherapy.

31. Method according to claim 30, characterized in that measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the first and / or second biological samples comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

32. Method according to claim 30 or 31, characterized in that the concentration level of at least tetranectin is measured.

33. Method for diagnosing and treating pancreatic cancer in an individual, characterized in that the method comprises: (a) providing a first biological sample obtained from the individual; (b) at a first point in time, measuring the concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, or complement factor C6, and fibronectin from the sample obtained;(c) compare the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, in the sample obtained with reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a pancreatic cancer-negative sample and / or a sample obtained at a previous time point in the individual; (d) at a second time point, measure the concentration levels of at least one, at least two, at least three, at least four, or at least five pancreatic cancer-related proteins, or peptide fragments thereof, selected from apolipoprotein A1;apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b or complement factor C6, and fibronectin in a second biological sample obtained from the individual; (e) compare the concentration levels at the second time point of pancreatic cancer-related proteins, or peptide fragments thereof, from the sample obtained with the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from a pancreatic cancer-negative sample and / or from a sample obtained at the first time point or at the individual's previous time point;(f) identify the individual as having pancreatic cancer or at risk of having pancreatic cancer if the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of the first and second samples obtained are different from the reference concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of the pancreatic cancer-negative sample and / or from a sample obtained at the first point in time; and (g) optionally, treat or cause the treatment of the individual if so identified as having pancreatic cancer with a pancreatic cancer treatment regimen.

34. Method according to claim 33, characterized in that the identification step (f) occurs after determining that the concentration levels of at least one, at least two, at least three, at least four, or at least five of the pancreatic cancer-related proteins, or peptide fragments thereof, in the obtained sample are elevated by about 10% or more, about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the concentration levels of the reference pancreatic cancer-related proteins, or peptide fragments thereof, in the pancreatic cancer-negative sample.

35. Method according to claim 33, characterized in that the identification step (f) occurs after determining that the concentration levels of at least three, at least four, or at least five of the pancreatic cancer-related proteins, or peptide fragments thereof, in the obtained sample are elevated by about 10% or more, about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, or about 70% or more relative to the concentration levels of the reference pancreatic cancer-related proteins, or peptide fragments thereof, in the pancreatic cancer-negative sample.

36. Method according to claim 33, characterized in Petition 870250095163, dated 10 / 17 / 2025, page 84 / 185 16 / 19 by the fact that measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, from the first and / or second biological samples comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, phospholipid transfer protein, and fibronectin.

37. Method according to any one of claims 33 to 36, characterized in that the concentration level of at least tetranectin is measured.

38. A method according to any one of claims 33 to 37, characterized in that the sample obtained is blood or urine, or is serum, plasma or urine.

39. A method according to any one of claims 33 to 38, characterized in that pancreatic cancer-related proteins, or peptide fragments thereof, are measured by a spectroscopic technique, wherein the spectroscopic technique is selected from the group consisting of liquid chromatography, gas chromatography, liquid chromatography mass spectrometry, gas chromatography mass spectrometry, high-performance liquid chromatography mass spectrometry, capillary electrophoresis mass spectrometry, nuclear magnetic resonance (NMR) spectrometry, Raman spectrometry and infrared spectrometry.

40. A method according to any one of claims 33 to 39, characterized in that the comparison of the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of the obtained sample with the concentration levels of reference pancreatic cancer-related proteins, or peptide fragments thereof, of the pancreatic cancer-negative sample comprises multivariate statistical analysis.

41. Method according to any of the claims Petition 870250095163, dated 10 / 17 / 2025, pp. 85 / 185 17 / 19 33 to 40, characterized in that measuring the concentration levels of pancreatic cancer-related proteins, or peptide fragments thereof, of the second biological sample comprises measuring at least one, at least two, at least three, or each of L-selectin, tetranectin, and phospholipid transfer protein, and wherein if the measured levels of L-selectin, tetranectin, and / or phospholipid transfer protein in the second biological sample, when compared to the respective concentration levels measured at the first point in time, are elevated by at least 10%, 15%, 20%, or 25%, the individual is identified as having pancreatic cancer or as having a risk of having pancreatic cancer.

42. A method according to any one of claims 33 to 41, characterized in that the concentration level of at least fibronectin is measured, and in that if the measured level of fibronectin in the second biological sample, when compared to a respective concentration level measured at the first point in time, is elevated or decreased by at least 10%, 15%, 20% or 25%, the individual is identified as having pancreatic cancer or as having a risk of having pancreatic cancer.

43. A proteolyzed sample for use in mass spectrometry to diagnose pancreatic cancer in an individual, characterized in that it comprises one or a combination of peptide fragments of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, L-selectin, tetranectin, phospholipid transfer protein, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, and fibronectin.

44. Proteolyzed sample for use in mass spectrometry to diagnose pancreatic cancer in an individual, characterized in that it comprises a peptide fragment of L-selectin, Petition 870250095163, 10 / 17 / 2025, p. 86 / 185 18 / 19 tetranectin, phospholipid transfer protein and / or fibronectin.

45. A method according to any of the preceding claims, characterized in that it further comprises obtaining a biopsy sample from an individual identified as having a risk of having pancreatic cancer after measuring pancreatic cancer proteins or fragments thereof and, if cancer cells are identified in the sample, surgically removing the cancerous tissue from the pancreas and / or bile duct(s) of the individual.

46. ​​Method or kit according to any one of claims 1 to 45, characterized in that Tetranectin levels increase over time, in the manner measured at two or more time points, over a period of 1 month to 3 years, or are elevated at a single time point relative to a control.

47. A method or kit according to any one of claims 1 to 45, characterized in that it further comprises measuring the levels of at least one of L-selectin and phospholipid transfer protein, and in which the levels of at least one of L-selectin and phospholipid transfer protein increase over time, in the manner measured at two or more time points, over a period of 1 month to 3 years, or are elevated at a single time point relative to a control.

48. A method according to claim 46, characterized in that it further comprises measuring the levels of at least one of L-selectin and phospholipid transfer protein, and wherein the levels of at least one of L-selectin and phospholipid transfer protein increase over time, in the manner measured at two or more time points, over a time period of 1 month to 3 years, or are elevated at a single time point relative to a control.

49. Method or kit according to any of the claims 46 to 48, characterized in that it further comprises measuring the levels of L-selectin and phospholipid transfer protein, and in that the levels of L-selectin and phospholipid transfer protein increase over time, in the manner measured at two or more points in time, over a period of 1 month to 3 years, or are elevated at a single point in time relative to a control.

50. Method or kit according to any one of claims 46 to 49, characterized in that it additionally comprises measuring fibronectin.

51. A method or kit according to any one of claims 46 to 50, characterized in that it further comprises measuring at least one of apolipoprotein A1, apolipoprotein A-II, plasma protease inhibitor C1, apolipoprotein M, gelsolin, adipocyte plasma membrane-associated protein, complement factor C1s, complement factor C4b, complement factor C6, or a combination thereof.

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