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Columbia Pancreatic Cancer Prevention Program Registry and Tissue Bank for High Risk Individuals

18 Years
85 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Columbia Pancreatic Cancer Prevention Program Registry and Tissue Bank for High Risk Individuals

Pancreatic cancer is the fourth leading cause of death resulting from malignancy in both men
and women. Approximately 30,500 individuals in the United States will be diagnosed with
pancreatic cancer in 2004, and it is expected that 29,100 will die from the disease. The
death rate and incidence are virtually identical. It is now known that 4-16% of pancreatic
cancers are either inherited or familial. There is still much to be discovered about the
etiology of inherited, familial, and sporadic pancreatic cancers. Studies of this type
require a database of detailed personal and family history, with accompanying blood, and
when available, fixed and fresh tissue. The aims of this project are to create a registry,
and blood and tissue bank for individuals at risk for pancreatic cancer. The personal data
will be derived by a study questionnaire. A portion of the collected white blood cells will
be immortalized by EBV infection. At the time of any tumor resection, tumor and adjacent
normal tissue will be requested from the Pathology Department. No additional tissue will be
resected beyond that required for surgical management. The epidemiological data can be
correlated with the biological information and 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 and hypothesized that the knowledge derived will ultimately lead to improvements
in the diagnosis, prevention, detection, and treatment of pancreatic cancer.

Inclusion Criteria:

- The modified clinical Bethesda criteria for 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 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Creation of a registry and blood/tissue bank

Outcome Description:

The primary aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Harold Frucht, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

June 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Pre-Neoplastic Lesions
  • Pancreatic Cancer Surgery
  • High-Risk for Pancreatic Cancer
  • Tissue and Blood Bank for Pancreatic Cancer
  • Pancreatic Cancer Questionnaire
  • Pancreatic Neoplasms



Columbia University Medical CenterNew York, New York  10032