NCT01102556 PANCREATIC DISEASE COHORT A Registry and Biospecimen Bank to Better Understand Pancreatic Disease
| NCT ID | NCT01102556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2004-07 |
| Primary Completion | 2030-12 |
Trial Parameters
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Brief Summary
The specific aims of this project are to create a registry, as well as a biospecimen bank for individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis, intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic intraepithelial neoplasia (PanIN) or have been determined to be at high-risk for pancreatic cancer. Biospecimen can be defined as blood, urine, tissue, stool, or saliva samples. Therefore, no hypothesis is to be tested. The personal data derived from the registry, correlated with biological information derived from the biospecimens will allow for future investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. It is anticipated that the knowledge derived will ultimately lead to improvements in the diagnosis, prevention, detection,and treatment of pancreatic cancer.
Eligibility Criteria
Inclusion Criteria: * Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas who are 18 years or older * Individuals identified to be high risk for developing pancreatic cancer who are 18 years or older based on the following criteria: * The modified clinical Bethesda criteria for hereditary nonpolyposis colorectal cancer (HNPCC), which are as follows: individuals with 2 HNPCC-associated cancers (colon, endometrial, small bowel, hepatobiliary, pancreatic, genitourinary, or gastric), including synchronous or metachronous lesions; individuals with colon cancer and a first degree relative with an HNPCC-associated tumor and/or colonic adenoma (1 cancer diagnosed at age \<45 years and the adenoma diagnosed at age \<40 years); individuals with colon or endometrial cancer diagnosed at \<50 years; individuals with right-sided colon cancer having an undifferentiated pattern (solid/cribiform) or signet cell histopatho
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