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

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.

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.