Cancer screening method

Abstract

A cancer screening method takes advantage of the Warburg Effect to provide an early detection method and system. The cancer screening method includes administering a glucose solution, such as a C-13 glucose solution, measuring a metabolized lactate level in the blood of the individual after a period of time following the administration of the glucose solution, and comparing the measured lactate level to a baseline lactate level representative of noncancerous activity, and making a determination as to whether or not the measured lactate level is potentially indicative of cancer activity in the individual. The period of time is selected to be an amount of time following the glucose administration after which metabolized lactate from cancerous cells would be present in the blood and before which the metabolized lactate would be cleared or substantial amounts of non-cancerous metabolized lactate would be present in the blood of the individual.

Description

PCT International Patent Application for:CANCER SCREENING METHODInventor(s):1. Eric Sacknoff17 Wallace CourtRockville Centre, NY 11570RESIDENCE: Rockville Centre, NYAssignee: InventorEntity: SMALLDocket No.: SAC.201.PCTCERTIFICATE OF EXPRESS MAILING OR ELECTRONIC FILING:Date of Deposit or Filing: December 22, 2025I hereby certify that this paper is being deposited with the United States Postal Service “Express Mail Post Office to Addressee” service under 37 CFR 1.10 on the date indicated above and is addressed to: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450 or is being electronically submitted via EFS on the date shown below.“Express Mail” mailing label number (if applicable) NA_ Guy V. Tucker _ _ / Guy V. Tucker / _Name of Person Mailing or Filing Paper Signature of Person Mailing Paper or Filing PaperCANCER SCREENING METHODPRIORITY

[0001] The present application claims the benefit of domestic priority based on United States Provisional Patent Application 63 / 736,776 filed on December 20, 2024, the entirety of which is incorporated herein by reference.BACKGROUND

[0002] The early detection of cancer activity is of paramount importance. Early cancer detection can dramatically improve treatment success, survival rates, and quality of life. Finding cancer when it's small, localized, and easier to treat, often prevents it from spreading and can increase the likelihood for less aggressive treatment therapies to be utilized.

[0003] Existing early cancer screening techniques are useful, but they suffer from certain disadvantages or drawbacks. For example, many cancer screening techniques are designed to identify a particular type of cancer, with common examples being Pap / HPV for cervical cancer, mammography for breast cancer, colonoscopy or stool tests for colorectal cancer, and low-dose computed tomography for lung cancer. While effective for detecting the type of cancer being looked for, these techniques will likely miss other cancers that may be growing in the body. Newer multi-cancer detection (MCD) tests have been developed. However, these tests involve complex DNA and / or protein testing procedures with high out of pocket costs.

[0004] Therefore, there is a need for an improved cancer screening method. There is a further need for an early cancer screening method that is useful in detecting multiple types of cancer. There is a further need for an early cancer screening method that involves a simple blood test. There is a further need for an early cancer screening method that is convenient, easily administered, and / or affordably administered.SUMMARY

[0005] The present invention satisfies one or more of these needs. In one aspect of the invention, an improved cancer screening method is provided.

[0006] In another aspect of the invention, a cancer screening method is provided that is capable of early detection of multiple types of cancerous activity.

[0007] In another aspect of the invention, a cancer screening method is provided that involves a simple blood test.

[0008] In another aspect of the invention, an early cancer screening method is provided that is convenient, easily administered, and / or less expensive that existing screening tests.

[0009] In another aspect of the invention, a cancer screening method comprises measuring a metabolized lactate level in an individual being screened.

[0010] In another aspect of the invention, a cancer screening method comprises measuring a metabolized lactate level in an individual being screened, and determining if the measured metabolized lactate level is potentially indicative of cancer activity.

[0011] In another aspect of the invention, a cancer screening method comprises measuring a metabolized lactate level in an individual being screened, and comparing the measured metabolized lactate level to a healthy metabolized lactate baseline level to identify abnormal metabolic activity.

[0012] In another aspect of the invention, a system or kit is provided for facilitating a cancer screening method as described herein.

[0013] In another aspect of the invention, a system or kit is provided for facilitating an at-home cancer screening method as described herein.

[0014] In another aspect of the invention, an automatic lactate testing device is provided.

[0015] In another aspect of the invention, a kit for cancer screening comprises the components needed to practice a cancer screening method as described herein and using the kit to administer a cancer screening method as described herein.

[0016] In another aspect of the invention, a cancer screening method comprises administering a glucose solution to an individual; measuring a lactate level in the blood of the individual after a period of time following the administration of the glucose solution; comparing the measured lactate level to a baseline lactate level representative of non-cancerous activity; and making a determination as to whether or not the measured lactate level is potentially indicative of cancer activity in the individual.

[0017] In another aspect of the invention, a cancer screening method comprises administering a glucose solution to an individual; measuring a lactate level in the blood of the individual after a period of time following the administration of the glucose solution; comparing the measured lactate level to a baseline lactate level representative of non-cancerous activity; and making a determination as to whether or not the measured lactate level is potentially indicative of cancer activity in the individual, wherein the period of time is selected to be an amount of time following the glucose administration after which metabolized lactate from cancerous cells would be present in the blood of the individual and before which the metabolized lactate would be cleared or substantial amounts of non-cancerous metabolized lactate would be present in the blood of the individual.

[0018] In another aspect of the invention, a cancer screening method comprises administering a glucose solution to an individual; measuring a lactate level in the blood of the individual after a period of time following the administration of the glucose solution; comparing the measured lactate level to a baseline lactate level representative of non-cancerous activity; and making a determination as to whether or not the measured lactate level is potentially indicative of cancer activity in the individual, wherein the period of time is selected to be an amount of time following the glucose administration after which metabolized lactate from cancerous cells would be present in the blood of the individual and before which the metabolized lactate would be cleared or substantial amounts of non-cancerous metabolized lactate would be present in the blood of the individual, and wherein the glucose solution comprisesCarbon- 13 labeled glucose and wherein step of measuring a lactate level in the blood comprises measuring a Carbon- 13 labeled lactate level in the blood.

[0019] In another aspect of the invention, a cancer screening method comprises administering a glucose solution to an individual; measuring a lactate level in the blood of the individual after a period of time following the administration of the glucose solution; comparing the measured lactate level to a baseline lactate level representative of non-cancerous activity; and making a determination as to whether or not the measured lactate level is potentially indicative of cancer activity in the individual, wherein the period of time is selected to be an amount of time following the glucose administration after which metabolized lactate from cancerous cells would be present in the blood of the individual and before which the metabolized lactate would be cleared or substantial amounts of non-cancerous metabolized lactate would be present in the blood of the individual, and wherein the baseline lactate level is based on historic baseline levels for the individual.

[0020] In another aspect of the invention, system or kit for performing a cancer screening method comprises a container comprising a glucose solution and a blood information collection member, wherein the container comprising a glucose solution and the blood information collection member can be used to perform a cancer screening method as described herein.

[0021] In another aspect of the invention, system or kit for performing a cancer screening method comprises a container comprising a glucose solution and a blood information collection member, wherein the container comprising a glucose solution and the blood information collection member can be used to perform a cancer screening method as described herein, and wherein the system or kit is in the form of an at-home kit.

[0022] In another aspect of the invention, system or kit for performing a cancer screening method comprises a container comprising a glucose solution and a blood information collection member, wherein the container comprising a glucose solution and the blood information collection member can be used to perform a cancer screening method as described herein, and wherein the blood information collectionmember comprises an automatic blood analyzer adapted to receive information about the blood of the individual and to automatically measure and display a lactate level.

[0023] In another aspect of the invention, system or kit for performing a cancer screening method comprises a container comprising a glucose solution and a blood information collection member, wherein the container comprising a glucose solution and the blood information collection member can be used to perform a cancer screening method as described herein, and wherein the blood information collection member comprises an automatic blood analyzer adapted to receive information about the blood of the individual and to automatically measure and display a C-13 lactate level.

[0024] In another aspect of the invention, system or kit for performing a cancer screening method comprises a container comprising a glucose solution and a blood information collection member, wherein the container comprising a glucose solution and the blood information collection member can be used to perform a cancer screening method as described herein, and wherein the blood information collection member comprises an automatic breath analyzer adapted to receive a breath from the individual and to automatically measure and display a lactate level.

[0025] In another aspect of the invention, system or kit for performing a cancer screening method comprises a container comprising a glucose solution and a blood information collection member, wherein the container comprising a glucose solution and the blood information collection member can be used to perform a cancer screening method as described herein, and wherein the blood information collection member comprises an automatic breath analyzer adapted to receive a breath from the individual and to automatically measure and display a C-13 lactate level.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] These features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, andaccompanying drawings which illustrate exemplary features of the invention.However, it is to be understood that each of the features can be used in the invention in general, not merely in the context of the particular drawings, and the invention includes any combination of these features, where:

[0027] Figure 1 is a schematic flow chart of a version of a cancer screening method of the invention;

[0028] Figure 2 is a schematic flow chart of another version of a cancer screening method of the invention;

[0029] Figure 3 is a schematic flow chart of another version of a cancer screening method of the invention;

[0030] Figure 4 is a schematic flow chart of another version of a cancer screening method of the invention;

[0031] Figure 5 is a schematic flow chart of another version of a cancer screening method of the invention;

[0032] Figure 6 is a schematic flow chart of another version of a cancer screening method of the invention;

[0033] Figure 7 is a schematic flow chart of another version of a cancer screening method of the invention;

[0034] Figure 8 is a schematic representation of a system or kit for practicing a cancer screening method of the invention;

[0035] Figure 9 is a schematic representation of another version of a system or kit for practicing a cancer screening method of the invention;

[0036] Figure 10A is a schematic side view of an automatic testing device that can be used to practice the cancer screening method of the invention;

[0037] Figure 10B is a schematic side view of another version of an automatic testing device that can be used to practice the cancer screening method of the invention;

[0038] Figure 11 A is a schematic side view of another version of an automatic testing device that can be used to practice the cancer screening method of the invention; and

[0039] Figure 1 IB is a schematic side view of another version of an automatic testing device that can be used to practice the cancer screening method of the invention.DESCRIPTION

[0040] The present invention relates to a cancer screening method. In particular, the invention relates to an early stage cancer screening method involving a blood test. Although the invention is illustrated and described in the context of being useful for early screening of cancerous activity, the present invention can be used in other ways, as would be readily apparent to those of ordinary skill in the art. Accordingly, the present invention should not be limited just to the examples and embodiments described herein.

[0041] Figure 1 shows a version of a cancer screening method 100 of the invention. The cancer screening method 100 comprises prepping 105 an individual that is to be screened for cancerous activity, for the screening, taking a blood sample 110 from the individual, testing the blood sample to obtain 115 information about the presence and / or amount of metabolized lactate in the blood, and determining 120 if the lactate level is potentially indicative of cancerous activity. If not, the individual can be informed 125 of a negative test, and if so, further investigative action can be taken, such as recommending 130 that the individual undertake additional testing and / or see a specialist.

[0042] The cancer screening method 100 utilizes the Warburg Effect to make an early and / or preliminary recognition of potential cancerous activity. The Warburg Effect is a phenomenon discovered by Otto Warburg in 1927. Warburg demonstrated that tumor cells uptake and metabolize glucose differently than healthy, or non-tumorous, cells. By sampling and analyzing the blood of an individual under prescribed conditions, the cancer screening method 100 of the present invention can use the recognition of abnormal amounts of metabolized lactate as an indicator of possible cancerous activity.

[0043] Glucose is metabolized by a cellular process called glycolysis. In healthy cells, glucose is broken down into pyruvate molecules. In the presence of oxygen, the pyruvate molecules enter the mitochondria for Krebs cycle conversion to energy. When abundant oxygen is not present, at least a portion of the pyruvate molecules are converted to lactate. In tumorous cells, as discovered by Warburg, lactate metabolism occurs at an increased amount. In particular it has been discovered that lactate metabolism occurs in the presence of oxygen at a significantly higher rate than in non- cancerous cells. Accordingly, the cancer screening method 100 of the present invention tests for an abnormally high lactate concentration in blood as an early indicator of the possibility of there being cancerous cells in the individual. For example, when more lactate has been metabolized under certain prescribed conditions than would be expected from an individual with healthy cells, there is at least a possibility that the increased lactate is due to cancer cells causing an increased amount of pyruvate molecules to be converted into lactate.

[0044] Figure 2 shows another version of a cancer screening method 100 of the invention. In the version of Figure 2, the step of determining 120 if lactate levels in the blood are potentially indicative of cancer activity comprises comparing the measured metabolized lactate level to a healthy or expected lactate level under certain prescribed conditions. As shown in Figure 2, the determining step 120 thus obtains information related to a healthy baseline level 205 and then analyzes 210 the tested individual’s lactate level to determine if the tested level is abnormally high relative to the healthy level. If yes, the individual may need further testing to more accurately determine the cause of the elevated metabolized lactate level and whether the cause is related to cancerous activity. The healthy metabolized lactate baseline level is representative of a lactate level in individuals that have no cancerous activity and can be determined through empirical or clinical studies and / or can be accessed from a database or lookup table for individuals with similar characteristics, such as sex, age, weight, activity level, and the like, as the individual being tested and / or can be based on the individual’s own history, as will be further explained.

[0045] In order to be as accurate as possible, the cancer screening method 100 relies on a consistent and reproducible testing protocol designed to create conditions in which lactate that is abnormally metabolized due to cancerous activity can berecognizable from lactate that is normally metabolized. It is also important that the amount of abnormally metabolized lactate is of a measurable amount so as to be distinguished from regular fluctuations in lactate concentrations in the blood.

[0046] Figure 3 shows another version of a cancer screening method 100 in which a controlled or prescribed conditions are employed to help isolate and recognize lactate that is present due to abnormal metabolization. In the version of Figure 3, the step of prepping 105 an individual for a cancer screening comprises administering glucose to the individual by having the individual ingest 305 a glucose solution containing a dissolved, known amount of glucose. Preferably, the individual is asked to avoid food and exercise for a period of time, such as an hour, prior to the ingesting 305 of the glucose solution. After the glucose solution is ingested, the individual is asked to wait 310 for a period of time, T, without food or exercise. During this period of time, the cells of the individual metabolize the glucose in the ingested solution. In a healthy individual, due to the lack of exercise creating aerobic conditions, little or no glucose will be converted to lactate. However, in cancerous cells, a significant amount of lactate will be generated. Therefore, the period of time, T, is selected to be an amount of time following the glucose administration 305 after which metabolized lactate from cancerous cells would be present in the blood of the individual, if the individual has cancerous activity occurring, and before which the metabolized lactate would be cleared and / or before substantial amounts of non-cancerous metabolized lactate would be present in the blood of the individual, if the individual has no cancerous activity. Accordingly, by sampling 110 the individual’s blood after the period, T, an elevated presence of metabolized lactate can be considered indicative of the possibility of cancerous activity.

[0047] The selection of the time period, T, during which the glucose is allowed to metabolize prior to sampling 110 the individual’s blood, can be selected to provide a detectable indication of the presence of abnormally metabolized lactate. If the period is too short, there may not be sufficient time for the lactate to be generated. If the period is too long, healthily metabolized lactate may be present and / or lactate in the blood may begin to be broken down or cleared. The selected period, T, can depend on a number of factors including the amount and concentration of the glucose administered. In addition, conditions of the individual, such as age, weight, height,health, and the like, can affect the period. In one version, the time period, T, can be from about 30 minutes to 90 minutes, or from about 40 minutes to about 75 minutes, or from about 45 minutes to 60 minutes, or about 45 or about 60 minutes for a 0.1 percent to 10 percent (w / v) glucose solution in a young adult patient of average weight. Alternatively, and more accurately, the time period, T, can be empirically and / or clinically determined by testing with known healthy and known diseased individuals to ascertain the time period, T, when the most identifiable amount of abnormally metabolized lactate will be present in the blood of an individual with cancerous activity.

[0048] Another version of a cancer screening method 100 of the invention is shown in Figure 4. The version of Figure 4 is similar to the version of Figure 3, but in the version of Figure 4, the step 305 of ingesting a glucose solution comprises ingesting 405 a Carbon- 13 (C-13) labeled glucose solution. C-13 labeled glucose is a nonradioactive form of sugar where some or all of the Carbon- 12 atoms are replaced with the heavier, stable Carbon- 13 isotope. The Carbon- 13 serves as a metabolic tracer to track the metabolism of the ingested glucose. Lactate that metabolized from the C-13 glucose will also be labeled with the C-13 tracer. Accordingly, a measurement 410 of the C-13 lactate that is present will only measure the amount of lactate that is metabolized from the ingested 305 glucose solution. This provides a more accurate or focused assessment of the lactate levels that result only from the ingested 305 glucose and substantially eliminates artifacts that may be presented from lactate that is in the blood sample unrelated to the cancer screening method 100. Thus, by only analyzing 415 the C-13 lactate levels, a more accurate result can be achieved.

[0049] Another version of a cancer screening method 100 of the invention is shown in Figure 5. The version of Figure 5 is similar to the version of Figure 3, but in the version of Figure 5, the step 105 of prepping an individual for the cancer screening comprises taking a preliminary blood sample 505 from the individual prior to the individual ingesting 305 the glucose solution. Preferably, the individual is asked to go without food and / or exercise for a period of time, such as an hour, prior to the preliminary blood sampling 505. In this version, the step 115 of measuring the metabolized lactate comprises measuring the difference 510 between lactate in the preliminary blood sample and the lactate in the blood sample taken after ingesting 305the glucose solution to better isolate the lactate that is metabolized as a result of the glucose solution.

[0050] Both the version of Figure 4 and the version of Figure 5 provide methods of more accurately identifying and accounting for the lactate metabolism. In either of the versions of Figures 4 and / or Figure 5, the step 210 of comparing the metabolized lactate to a baseline 205 can be baselines that are obtained or measured using similar methodology as practiced in the respective versions. In another version, the cancer screening method 100 can comprise both a labeled glucose solution administration as in the version of Figure 4 and a preliminary blood sample as in the version of Figure 5 for even additional accuracy.

[0051] Another version of a cancer screening method 100 of the invention is shown in Figure 6. The version of Figure 6 is similar to the version of Figure 3, optionally including the steps of the versions of Figure 4 and / or Figure 5, but in the version of Figure 6, a timewise profile of lactate metabolism is measured rather than at measuring the metabolized lactate level at a single time point. As can be seen, in this version the step 310 of having the individual wait for a time period, T, comprises having the individual wait 605 for multiple time periods, T, and taking a blood sample 610 at the end of each of the multiple time periods. By taking multiple blood samples at different times following the ingestion 305 of the glucose solution, a metabolized lactate time based profile can be generated 615. In its simplest form, the time based profile will include a measured metabolized lactate level at two time points. In more complex versions, additional time points can be measured to create a profile curve. In this version, in the step 120 of determining if lactate levels are potentially indicative of cancer activity, the lactate baseline level 205 can comprise a lactate baseline time profile 620 that includes expected or healthy metabolized lactate levels at multiple times after in the ingestion 305 of glucose solution. The measured individual’s profile is then compared 625 to the baseline profile. The time profile not only provides for addition data points to be compared to a baseline profile, thereby increasing the accuracy of the determination, it also allows for the beginning or onset of lactate metabolism to be determine or estimated. In addition to an increase in the lactate level, an increase in the rapidity with which lactate starts to result from the metabolism can be indicative of cancerous activity.

[0052] The time periods, T, for waiting 605 in the version of Figure 6 can be the same or can be different. For example, in one version, the waiting period can be 15 minutes so that blood samples are taken 15 minutes, 30 minutes, 45 minutes, and one hour after the ingestion 305 of the glucose solution or every 20 minutes so that blood samples are taken 20 minutes and forty minutes after the ingestion 305 of the glucose sample. In another version, the wait periods are different. For example, the first wait period may be 30 minutes and a second wait period can be 15 minutes so that a first blood sample is taken at 30 minutes and a second blood sample is taken at 45 minutes after the ingestion 305 of the glucose solution. The higher the number of measurements, the greater the information and the greater the chance for an accurate screening. However, the taking of blood samples can be inconvenient and / or uncomfortable for the individual. Accordingly, in one version, non-invasive lactate measurements can be used, as will be described.

[0053] In any of the versions of Figures 2 through 6 and combinations thereof described above, the cancer screening method 100 relies on a meaningful healthy metabolized lactate baseline level 205 for comparing to the individual’s metabolized lactate level. In a simple version of the invention, the healthy metabolized baseline level 205 can be a threshold value, and when the measured metabolized lactate level of an individual exceeds the threshold value, the determination 120 can be that additional testing is recommended 130. In a more advanced and / or accurate version, the healthy metabolized lactate level 205 can vary based on one or more variables. For example, the healthy metabolized lactate level 205 can vary based on one or more of the individual’s age, the individual’s gender, the individual’s weight or body mass, the individual’s activity level or heartrate, the time period or periods, T, the concentration or amount of glucose administered, and the like. A data base or the like of such variable baselines can be accessed during step 205 to provide a healthy baseline against which to compare 210 the individual’s measured metabolized lactate level or levels. In one version, the baseline level 205 is determined from empirical and / or clinical data taken from numerous healthy and diseased patients with the resulting data being analyzed to produce average values or the like that indicate a possibility of cancerous activity.

[0054] In one version, the healthy metabolized lactate baseline level 205 is formed, at least in part, from data from the individual being screened and the individual’s history. For example, Figure 7 shows a version of a cancer screening method 100 in which the metabolized lactate baseline level 205 is compiled from previous screenings of the individual. The version of Figure 7 shown is similar to the version of Figure 3 but is also applicable to any of the versions shown and discussed. As can be seen in Figure 7, when a determination at step 210 is made that there is no indication of an abnormally high metabolized lactate level, the data related to the individual’s measurement 115 is stored 705 for future reference. In subsequent cancer screenings using the cancer screening method 100, the step 205 of obtaining healthy metabolized lactate baseline can include accessing 710 the stored values 705. With this version, an individual can be screened periodically, such as at every checkup or annually, and a record or compilation of the healthy tests can be stored. When the individual begins to demonstrate variation from the individual’s past levels, this can be a particularly sensitive and / or accurate early indication of cancerous activity.

[0055] The cancer screening method 100 of the invention, as described above, involves the measurement of the concentration of components in the blood. More specifically, in one or more versions, the method comprises the measurement of lactate concentration in the individual’s blood. In Figures 1 through 7, this is embodied by the steps of taking a blood sample 110 and measuring lactate level 115 in the blood sample. By taking a blood sample it is meant in any way accessing the blood of an individual in a manner where the concentration of lactate or other component can be identified and analyzed. For example, the step of taking a blood sample can be by directly obtaining a portion of the individual’s blood, such as by drawing blood from a vein by venipuncture, by capillary sampling via a finger prick or the like. The step of taking a blood sample and / or measuring the lactate level can also or alternatively be by an indirect or non-invasive method, such as breath analysis, optical spectroscopy, electromagnetic sensors in wearable patches, iontophoretic patches, photoacoustic spectroscopy. In this regard, particularly with the indirect methods, the steps of taking a blood sample 110 and measuring lactate levels 115 may be simultaneously performed as a single step.

[0056] The cancer screening method 100 of the invention, as described above, involves the determination 120 of whether or not a lactate level in the blood of an individual is indicative of the possibility of cancerous activity. More specifically, in one or more versions, the method comprises the comparing 210 the individual’s lactate level with a healthy lactate level. The comparison 210 can be performed manually or automatically. For example, a physician or other medical practitioner can physically compare a measured value to a healthy value or table of healthy values. Alternatively, a computer or other controller can be used to make the comparison. In the latter case, the computer or controller can access a data base of healthy levels and / or profiles and can compare the measured levels of the individual and make and automatic determination based on the comparison. The computer or controller can factor additional variables into the determination, as discussed above. In the case of comparing multiple data points, time profiles, and / or curves, artificial intelligence or machine learning tools can be employed to perform the analysis and recognize abnormalities.

[0057] In one version, as shown in Figure 8, a system or kit 800 can be provided for practicing the cancer screening method 100 of the invention. The kit 800 includes a container of glucose solution 805, a blood information collecting member 810, such as blood collector, vial, and / or blood testing or analyzing equipment, and a set of instructions 815 that details the steps of the cancer screening method 100 according to any of the above versions or combinations thereof. The container of glucose 805 can contain a predetermined amount and concentration of glucose, either unlabeled, labeled with C-13, or labeled with a different tracer. In the particular version shown, the blood information collection member 810 comprises a vial for collecting and storing blood that is to be tested. Alternatively or additionally, the blood information collection member can comprise one or more of a strip onto which blood can be placed for testing, any other type of physical collection device, and / or non-invasive data collector, such as a breathalyzer or the like. The components of the system or kit 800 can be contained within a package 820 or can be separately packages and / or stored.

[0058] Figure 9 shows another version of a system or kit 800 for practicing the cancer screening method 100 of the invention. In the version of Figure 9, the system or kit800 is an at-home kit 900 for practicing the cancer screening method 100 or at least a portion of the cancer screening method 100. The at-home kit 900 can be mailed or otherwise distributed to an individual so that the individual can perform the cancer screening method 100 in the comfort of the individual’s home or other comfortable location. In the particular version shown, the at-home kit 900 includes a blood information collection member 810 that comprises a finger lancing or pricking device 905 and a vial 910 for securely collecting the blood from the finger prick. Any alternative blood information collection member 810, invasive or non-invasive, as discussed above or below can be substituted. After the individual collects the blood or blood data in accordance with the cancer screen method 100 protocol, the sends the information to a physician, lab, or the like so that the physician, lab, or the like can perform the determination step 120. In the particular version shown, an envelope 915 is provided for mailing in the vial 910. Alternatively, the vial 910 can be hand carried or data, especially in the case of automatic testing and / or non-invasive testing, can be called in or uploaded.

[0059] Figure 10A shows an automatic testing device 1000 that can be used to practice the cancer screening method 100 of the invention. In the version shown, the automatic testing device 1000 is designed and adapted to measure a lactate concentration in the blood. In the version of Figure 10A, the automatic testing device 1000 is a blood analyzer 1005. The automatic blood analyzer receives collected blood from an individual and internally performs one or more tests to determine components and / or concentrations of the components in the blood. In the particular version of Figure 10A, the automatic testing device is an automatic lactate testing device 1010. The automatic lactate testing device 1010 includes a housing 1015 containing internal circuitry and programming designed and adapted to test for a lactate level and displays 1020 the resulting lactate level. The automatic lactate testing device blood analyzer 1005 can be similar to conventional testing devices that test for glucose or other sugars, but programmed specifically to test for lactate, and in one version, lactate alone. Figure 10B shows an automatic lactate testing blood analyzer 1010, similar to the version of Figure 10A, but the version of Figure 10B the automatic lactate testing blood analyzer 1010 is an automatic C-13 lactate testing blood analyzer 1025 that is designed and adapted to test for C-13 lactate, and in one version, C-13 lactate alone, and to display 1030 a C-13 lactate level.

[0060] Figure 11 A shows another version of an automatic testing device 1000 that can be used to practice the cancer screening method 100 of the invention. In the version shown, the automatic testing device 1000 of Figure 11 A is designed and adapted to measure a lactate concentration in the blood. In the version of Figure 11 A, the automatic testing device 1000 is a breath analyzer 1100. The automatic breath analyzer 1100 receives an individual’s breath and internally performs one or more tests to determine from the breath components and / or concentrations of the components in the blood. In the particular version of Figure 11 A, the automatic breath analyzer 1100 is an automatic lactate testing breath analyzer 1105. The automatic lactate testing device breath analyzer 1105 includes a housing 1110 containing internal circuitry and programming designed and adapted to test for a lactate level in the blood by analyzing an individual’s breath from a mouthpiece 1115 and displays 1120 the resulting lactate level. The automatic lactate testing device breath analyzer 1105 can be similar to conventional breath analyzers that test for alcohol or the like, but programmed specifically to test for lactate, and in one version, lactate alone. Figure 1 IB shows an automatic lactate testing breath analyzer 1105, similar to the version of Figure 11 A, but the version of Figure 1 IB the automatic lactate testing breath analyzer 1010 is an automatic C-13 lactate testing breath analyzer 1125 that is designed and adapted to test for C-13 lactate, and in one version, C-13 lactate alone, and to display 1130 a C-13 lactate level.

[0061] In any of the above discussed cancer screening methods 100, a determination 120 that lactate levels are potentially indicative of cancer activity can be communicated to the individual with a recommendation for additional testing 130. In some cases, the additional testing may be a follow up test immediately or at a future date of the cancer screen method 100 of the invention. In more definitive determinations, the follow up may be a more conventional cancer test, such as a PET Scan. PET Scan screenings also take advantage of the Warburg Effect where a glucose solution is administered with a radioactive tracer that allows the areas of increased glycolytic activity to be imaged.

[0062] While glucose and C-13 glucose are used in the cancer screening method 100 as discussed above, alternatives that produce a similar effect can be used instead or in addition to the glucose and / or C-13 glucose. For example, Deuterium, Carbon-14,Nitrogen-15, and / or Oxygen-18 can be with or in place of C-13 to label the glucose.However, in one version, C-13 is preferred due to its stable nature.

[0063] This methodology and systems of the present invention thus enable enhanced venous serum differentiation to better detect tumorigenic cellular metabolism of glucose. The cancer screening method 100 of the invention aims to capitalize on the Warburg Effect by establishing a protocol of differentiating serum lactate levels commiserate with increased glucose metabolization by tumor cells.

[0064] The cancer screening method 100 comprises the administration of a glucose solution, preferably a Carbon 13 glucose solution, optionally obtaining a baseline venous, having an individual test subject ingest the glucose solution, after a sufficient glucose metabolizing wait period, obtain a test venous serum sample or date, and performing a blood assay protocol discerning the lactate, preferably the Carbon 13 lactate in the sample and comparing it to serum lactate in the baseline sample. If abnormal, the test may be used to further infer the presence of tumorigenic glycolysis.

[0065] The cancer screening method 100 can be used as an adjunctive measure to be collated and interpreted with other venous serum tumorigenic activity assay protocols. The basis for validity of the presented methodology is (i) tumor cells are known to uptake glucose faster than other cell lines (Warburg Effect), (ii) tumor cells are known to metabolize glucose faster than other cells (Warburg Effect), (iii) Carbon- 13 is a stable isotope of carbon, and (iv) the glycolysis rate differential between tumor cells and non-tumor cell lines provides a time window for predominantly tumorigenic lactate to be present in the individual’s blood.

[0066] The cancer screening method is thus intended to improve and enhance venous serum assay activity and analysis in determining cellular tumorigenic glycolysis. The ingested glucose, or C-13 glucose, will more rapidly be converted to lactate, or C-13 lactate, by tumor cells. This metabolic process enables a determination of tumorigenic glycolysis when venous serum is collected at a time interval that allows for tumor cell glycolysis but is prior to other cell line glycolysis, thusly leveraging the differentiation.

[0067] Although the present invention has been described in considerable detail with regard to certain preferred versions thereof, other versions are possible, and alterations, permutations and equivalents of the versions shown will become apparent to those skilled in the art upon a reading of the specification and study of the drawings. For example, the cooperating components may be reversed or provided in additional or fewer number, and all directional limitations, such as up and down and the like, can be switched, reversed, or changed as long as doing so is not prohibited by the language herein with regard to a particular version of the invention. Like numerals represent like parts from figure to figure. When the same reference number has been used in multiple figures, the discussion associated with that reference number in one figure is intended to be applicable to the additional figure(s) in which it is used, so long as doing so is not prohibited by explicit language with reference to one of the figures. Also, the various features of the versions herein can be combined in various ways to provide additional versions of the present invention. Furthermore, certain terminology has been used for the purposes of descriptive clarity, and not to limit the present invention. Throughout this specification and any claims appended hereto, unless the context makes it clear otherwise, the term “comprise” and its variations such as “comprises” and “comprising” should be understood to imply the inclusion of a stated element, limitation, or step but not the exclusion of any other elements, limitations, or steps. Throughout this specification and any claims appended hereto, unless the context makes it clear otherwise, the term “consisting of’ and “consisting essentially of’ should be understood to imply the inclusion of a stated element, limitation, or step and the exclusion of any other elements, limitations, or steps or the exclusion of any other essential elements, limitations, or steps, respectively. Throughout the specification, any discussion of a combination of elements, limitations, or steps should be understood to include (i) each element, limitation, or step of the combination alone, (ii) each element, limitation, or step of the combination with any one or more other element, limitation, or step of the combination, (iii) an inclusion of additional elements, limitations, or steps (i.e. the combination may comprise one or more additional elements, limitations, or steps), and / or (iv) an exclusion of additional elements, limitations, or steps or an exclusion of essential additional elements, limitations, or steps (i.e. the combination may consist of or consist essentially of the disclosed combination or parts of the combination). Allnumerical values, unless otherwise made clear in the disclosure or prosecution, include either the exact value or approximations in the vicinity of the stated numerical values, such as for example about + / - ten percent or as would be recognized by a person of ordinary skill in the art in the disclosed context. The same is true for the use of the terms such as about, substantially, and the like. Also, for any numerical ranges given, unless otherwise made clear in the disclosure, during prosecution, or by being explicitly set forth in a claim, the ranges include either the exact range or approximations in the vicinity of the values at one or both of the ends of the range. When multiple ranges are provided, the disclosed ranges are intended to include any combinations of ends of the ranges with one another and to include zero and infinity as possible ends of the ranges. Therefore, any appended or later filed claims should not be limited to the description of the preferred versions contained herein and should include all such alterations, permutations, and equivalents as fall within the true spirit and scope of the present invention.

Claims

What is claimed is:

1. A cancer screening method comprising: administering a glucose solution to an individual; measuring a lactate level in the blood of the individual after a period of time following the administration of the glucose solution; comparing the measured lactate level to a baseline lactate level representative of non-cancerous activity; and making a determination as to whether or not the measured lactate level is potentially indicative of cancer activity in the individual, wherein the period of time is selected to be an amount of time following the glucose administration after which metabolized lactate from cancerous cells would be present in the blood of the individual and before which the metabolized lactate would be cleared or substantial amounts of non-cancerous metabolized lactate would be present in the blood of the individual.

2. A cancer screening method according to claim 1 wherein the glucose solution comprises labeled glucose and wherein step of measuring a lactate level in the blood comprises measuring a labeled lactate level in the blood.

3. A cancer screening method according to claim 1 wherein the glucose solution comprises Carbon- 13 labeled glucose and wherein step of measuring a lactate level in the blood comprises measuring a Carbon- 13 labeled lactate level in the blood.

4. A cancer screening method according to claim 1 wherein the period of time is from about 30 minutes to about 60 minutes.

5. A cancer screening method according to claim 1 wherein the step of measuring a lactate level in the blood comprises measuring a first lactate level after a first period of time and measuring a second lactate level after a second period of time.

6. A cancer screening method according to claim 1 wherein the step of measuring a lactate level in the blood comprises measuring a first lactate level after about 30 minutes and measuring a second lactate level after about 45 minutes.

7. A cancer screening method according to claim 1 wherein the baseline lactate level is determined from representative lactate levels of non-cancerous individuals.

8. A cancer screening method according to claim 1 wherein the baseline lactate level is based on historic baseline levels for the individual.

9. A cancer screening method according to claim 1 wherein the step of measuring a lactate level in the blood comprises invasively collecting blood from the individual and testing the collected blood.

10. A cancer screening method according to claim 1 wherein the step of measuring a lactate level in the blood comprises non-invasively detecting a lactate level in the blood.

11. A cancer screening method according to claim 1 wherein the step of measuring a lactate level in the blood comprises non-invasively detecting a lactate level in the blood by breath analysis.

12. A cancer screening method according to claim 1 wherein the individual is asked to not eat or exercise between the step of administering a glucose sample and the step of measuring a lactate level in the blood.

13. A cancer screening method according to claim 1 wherein the method further comprises measuring a preliminary lactate level in the blood before the step of administering a glucose solution.

14. A system for performing a cancer screening method, the system comprising: a container comprising a glucose solution; and a blood information collection member, wherein the container comprising a glucose solution and the blood information collection member can be used to perform a cancer screening method comprising: administering the glucose solution to an individual;using the blood information collection member to measure a lactate level in the blood of the individual after a period of time following the administration of the glucose solution; comparing the measured lactate level to a baseline lactate level representative of non-cancerous activity; and making a determination as to whether or not the measured lactate level is potentially indicative of cancer activity in the individual, and wherein the period of time is selected to be an amount of time following the glucose administration after which metabolized lactate from cancerous cells would be present in the blood of the individual and before which the metabolized lactate would be cleared or substantial amounts of non-cancerous metabolizes lactate would be present in the blood of the individual.

15. A system for performing a cancer screening method according to claim 14 wherein the system is in the form of an at-home kit.

16. A system for performing a cancer screening method according to claim 14 wherein the blood information collection member comprises one or more of a vial, a finger lancing device, a blood analyzing device, and a non-invasive blood analyzing device.

17. A system for performing a cancer screening method according to claim 14 wherein the blood information collection member comprises an automatic blood analyzer adapted to receive information about the blood of the individual and to automatically measure and display a lactate level.

18. A system for performing a cancer screening method according to claim 14 wherein the container comprising a glucose solution comprises Carbon- 13 labeled glucose.

19. A system for performing a cancer screening method according to claim 18 wherein the blood information collection member comprises an automatic blood analyzer adapted to receive information about the blood of the individual and to automatically measure and display a C- 13 lactate level.

20. A system for performing a cancer screening method according to claim 14 wherein the blood information collection member comprises an automatic breath analyzer adapted to receive a breath from the individual and to automatically measure and display a lactate level.

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