Registry and biospecimen bank for pancreatic disease
PREDICT: Pancreatic Disease Cohort. A Registry and Biospecimen Bank To Better Understand Pancreatic Disease.
This study is collecting health information and samples from people with pancreatic disease or at high risk for pancreatic cancer to help improve understanding and treatment of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT01102556 on ClinicalTrials.gov |
What this trial studies
This project aims to create a registry and biospecimen bank for individuals diagnosed with pancreatic disease or those at high risk for pancreatic cancer. It will collect personal data and biological samples such as blood, urine, and tissue to facilitate future studies on pancreatic cancer etiology and tumor biology. The long-term goal is to enhance understanding of pancreatic cancer, ultimately leading to better diagnosis, prevention, detection, and treatment options. The study will enroll over 500 individuals annually to gather comprehensive data on this critical health issue.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with pancreatic cancer, pre-neoplastic lesions, or those identified as high-risk for developing pancreatic cancer.
Not a fit: Patients without a diagnosis of pancreatic disease or those not considered at high risk for pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly improve the understanding and management of pancreatic cancer, leading to better patient outcomes.
How similar studies have performed: While this approach is observational and aims to gather data rather than test a specific hypothesis, similar studies have contributed valuable insights into cancer research, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Beth Schrope, MD, PhD, FACS — Columbia University
- Study coordinator: Vilma Rosario
- Email: vr2222@cumc.columbia.edu
- Phone: 212-305-6033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.