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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2004-07 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 histopathology diagnosed at \<45 years; or individuals with adenomas diagnosed at \<40 years. * Those with a personal or family history of other pancreatic cancer associated syndromes including: Peutz-Jeghers syndrome, familial pancreatic cancer syndrome, familial breast cancer syndrome associated with BReast CAncer genes 1 or 2 (BRCA-2 or BRCA-1), hereditary pancreatitis, familial atypical multiple mole melanoma, and others. * Patients in a family with a genetically determined cancer predisposition syndrome. * Patients with a personal history of a gastrointestinal malignancy at age \<45 years. * Individuals at high-risk based on personal or family history, but not related to a known pancreatic cancer syndrome include the following: those with a personal history of pancreatic cancer, or a pre-neoplastic pancreatic lesion; those with a family history of two or more individuals with cancer, at least one of which is reported to be a gastrointestinal malignancy; a history of early onset (\<50 years) gastrointestinal cancer in the individual or a family member; a history of multiple primary cancers, at least one of which is a gastrointestinal primary, or a family member of an individual meeting this criterion. Exclusion Criteria: * Inability to obtain informed consent for study enrollment. * Under the age of 18 years old.
Contact & Investigator
Beth Schrope, MD, PhD, FACS
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT01102556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01102556 currently recruiting?
Yes, NCT01102556 is actively recruiting participants. Contact the research team at vr2222@cumc.columbia.edu for enrollment information.
Where is the NCT01102556 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT01102556 clinical trial?
NCT01102556 is sponsored by Columbia University. The principal investigator is Beth Schrope, MD, PhD, FACS at Columbia University. The trial plans to enroll 1,000 participants.
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