Microrna assay for detection and management of pancreatic cancer precursors
a pancreatic cancer and microrna technology, applied in the field of microrna assay for detection and management of pancreatic cancer precursors, can solve the problems of difficult management of mucinous cysts such as ipmns by patients and clinical teams, and the inability to reliably predict the degree of dysplasia, so as to increase the risk of developing
Inactive Publication Date: 2019-12-12
H LEE MOFFITT CANCER CENT & RES INST INC
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Benefits of technology
The patent text describes the discovery of specific microRNAs (miRNAs) that can be used to diagnose pancreatic cancer and to identify individuals who have a higher risk of developing the disease. These miRNAs can also help distinguish between pancreatic cancer and a non-cancerous condition called IPMN. The technical effect of this patent is that these miRNAs can serve as a tool to guide decisions regarding the monitoring, treatment, and management of pancreatic cancer.
Problems solved by technology
Intraductal papillary mucinous neoplasms (IPMN) are incidentally-detected pancreatic cysts that are challenging to manage due to the inability to predict which cysts can be safely monitored, which are likely to progress to invasive pancreatic cancer, and which may have an associated invasive component.
Differentiating between high-risk and low-risk intraductal papillary mucinous neoplasms (IPMNs) of the pancreas is a significant clinical problem.
Although improvements in imaging, cytology, and molecular studies have enabled proper classification and management of some benign non-neoplastic pancreatic cysts, mucinous cysts such as IPMNs are challenging for the patient and clinical team to manage due to the inability to accurately predict which lesions can be monitored, which are likely to progress to invasion, and which may have an associated invasive component.
However, these guidelines do not reliably predict the degree of dysplasia.
To date, the only way to treat IPMNs and accurately identify the grade of dysplasia is through surgical resection and pathological evaluation, but the risks of morbidity (i.e. long-term diabetes) and mortality associated with a Whipple procedure or a distal or total pancreatectomy may outweigh the benefits, especially for patients with LG disease.
Alternatively, taking a ‘watch and wait’ approach could lead to a missed opportunity to cure a patient harboring occult invasive disease.
Method used
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embodiment 1
[0097]A method of treating and / or preventing the development of pancreatic cancer in a subject, the method comprising:
[0098](a) detecting the level of expression of one or more miRNAs in a sample from the subject;
[0099](b) comparing the detected expression level to a reference expression level, wherein a differential expression of the one or more miRNAs in the sample, as compared to the reference expression level, is indicative of the presence of pancreatic cancer, or a higher risk of developing pancreatic cancer, versus the absence of pancreatic cancer, or a lower risk of developing pancreatic cancer, respectively; and
[0100](c) administering a therapy to treat and / or prevent the pancreatic cancer to the subject identified as having the pancreatic cancer, or at a higher risk of developing pancreatic cancer.
embodiment 2
[0101]The method of embodiment 1, wherein a differential expression of the one or more miRNAs in the sample, as compared to the reference expression level, is indicative of a pancreatic cancer precursor (such as intraductal papillary mucinous neoplasm (IPMN)) versus non-IPMN (normal cells).
embodiment 3
[0102]The method of embodiment 1, wherein a differential expression of the one or more miRNAs in the sample, as compared to the reference expression level, is indicative of a malignant intraductal papillary mucinous neoplasm (IPMN) versus a benign IPMN.
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The current invention pertains to miRNAs that are differentially expressed in samples of an individual having pancreatic cancer, or having a high risk of developing pancreatic cancer, as compared to the corresponding sample of an individual not having pancreatic cancer, or having low risk of developing pancreatic cancer, respectively. In certain embodiments, the miRNAs are differentially expressed in a tissue sample or blood plasma sample of an individual having a pancreatic lesion and having a high risk of developing pancreatic cancer as compared to the corresponding tissue sample or blood sample of an individual having the pancreatic lesion and having no risk or low risk of developing pancreatic cancer. These differentially expressed miRNAs can be used as biomarkers for diagnosis, treatment, and / or prevention of pancreatic cancer, particularly, in a subject having a pancreatic lesion. Microarray containing miRNAs indicative of the presence of pancreatic cancer, or having a high risk of pancreatic cancer development, particularly, in a subject having a pancreatic lesion, and methods of use of the microarrays are also provided.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application is a continuation of U.S. application Ser. No. 15 / 300,808, filed Sep. 30, 2016, now U.S. Pat. No. 10,240,208, which is the National Stage of International Application Number PCT / US2015 / 023702, filed Mar. 31, 2015, which claims the benefit of U.S. Provisional Application Ser. No. 61 / 973,068, filed Mar. 31, 2014, each of which is hereby incorporated by reference herein in its entirety, including any figures, tables, nucleic acid sequences, amino acid sequences, or drawings.GOVERNMENT SUPPORT[0002]This invention was made with government support under grant numbers CA076292 and CA129227 awarded by the National Institutes of Health. The government has certain rights in the invention.SEQUENCE LISTING[0003]The Sequence Listing for this application is labeled “21G0195.txt” which was created on Sep. 26, 2016 and is 13 KB. The entire contents of the sequence listing is incorporated herein by reference in its entirety.BACKGRO...
Claims
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IPC IPC(8): C12Q1/6886
CPCC12Q2600/118C12Q2600/178C12Q1/6886C12Q2600/158
InventorMALAFA, MOKENGE P.PERMUTH, JENNIFERCHEN, DUNG-TSA
OwnerH LEE MOFFITT CANCER CENT & RES INST INC