PANCREATIC DISEASE COHORT A Registry and Biospecimen Bank to Better Understand Pancreatic Disease

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT01102556

Collaborator

(none)

1,000

Enrollment

Location

317

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer

Detailed Description

Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. According to the American Cancer Society facts and figures, approximately 43,920 people in the United Sates will be diagnosed with pancreatic cancer in 2012, and it is expected that 37,390 will die from the disease. The dismal prognosis of the disease is clearly depicted by the fact that its incidence approximates its mortality. Pancreatic cancer has a 95% case fatality rate. The etiology of pancreatic cancer remains elusive and our knowledge of its precursors and natural history is preliminary and incomplete. The uniform fatality of the disease merits priority attention in the search for its cause.

Due to the rapid progression of the disease, early detection and prevention provides the best hope for reducing morbidity and mortality. However, the few screening tests available for early detection and/or prevention of neoplastic lesions are poorly studied and prohibitively impractical in the general population. Further, few pancreatic cancer risk factors are well established or widely accepted. Advanced age, family history, cigarette smoking, diabetes, and some dietary risk factors are established or suspected risk factors.

Due to the high volume of individuals seen at the pancreas center, we plan on enrolling 500+ individuals per year who have either been diagnosed with pancreatic disease or are at high risk for developing pancreatic cancer. All participants enrolled during a clinic/non clinic visit at Columbia University Medical Center (CUMC) will undergo a baseline visit and up to 3 subsequent visits. Additionally, based on the different conditions of pancreatic disease that we are enrolling, not all subjects will participate in all aspects of the program. For example, only individuals with cancer or pre-neoplastic lesions will have tissue collected and banked.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PREDICT: Pancreatic Disease Cohort. A Registry and Biospecimen Bank To Better Understand Pancreatic Disease.

Study Start Date :

Jul 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Dec 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Surgery Patients/High-risk Patients Patients who have undergone surgery for pancreatic cancer or pre-neoplastic lesions of the pancreas will be accrued to the study. In addition, patients who are determined to be at high-risk for pancreatic cancer (with a significant family history) will also be recruited for study enrollment.

Outcome Measures

Primary Outcome Measures

Creation of a registry and blood/tissue bank [1 year]
The primary aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer.

Secondary Outcome Measures

Improvement in the diagnosis, prevention, detection, and treatment of pancreatic cancer. [10 years]
The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. The epidemiological data will be correlated with the biological information and will allow for future investigative studies of pancreatic cancer etiology and tumor biology. It is anticipated and hypothesized that the knowledge derived will lead to improvements in the diagnosis, prevention, detection, and treatment of pancreatic cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.