Pancreatic Cancer Collaborative Registry
Pancreatic Cancer Collaborative Registry
RATIONALE: Gathering information about patients with cancer may help doctors learn more about
 the disease and plan early diagnosis and treatment.

 PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and
 treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a
 non-cancerous pancreatic disorder.
OBJECTIVES:

 -  Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and
 treatment of pancreatic cancer by using the power of computer and informatics sciences.

 -  Continue development of the Pancreatic Cancer Collaborative Registry (PCCR)
 infrastructure to act as a repository for socio-demographic, environmental, clinical,
 and family history data collected from individuals and interested family members with a
 personal and/or family history of pancreatic cancer.

 -  Participate in an international pancreatic registry known as the PCCR by sharing
 information collected for research purposes only, to be used by pancreatic cancer
 research collaborators from other institutions.

 -  Collect and bank excess biological materials (i.e., pancreatic tissue, tumor tissue,
 and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue), blood, and
 serum from registry participants for future research.

 OUTLINE: This is a multicenter study.

 Patients undergo blood and pancreatic tissue collection. Normal, tumor, and/or metastatic
 pancreatic cancer tissue, and/or paraffin-embedded tissue from prior surgery or biopsy are
 obtained.

 Patients provide or complete personal information about themselves, their medical history,
 their diet and lifestyle habits, any past or current environmental exposures, and re-create
 their family tree for any cancers that have occurred in any of their family members. Clinical
 data is collected annually.

 High Risk participants provide blood samples and complete questionnaires at baseline.
 Clinical data is collected annually.
DISEASE CHARACTERISTICS:

 -  Patients must meet 1 of the following criteria:

 -  Histologically confirmed adenocarcinoma of the pancreas

 -  Resectable stage I-IIA disease or stage IIB or higher disease

 -  Must have undergone complete surgical resection of the tumor with
 curative intent

 -  Pancreatic mass (solid) that is less than 4 cm as determined by any
 conventional imaging (MRI, EUS, or CT scan)

 -  No evidence of extension of the mass beyond the pancreas including vascular
 invasion or invasion into surrounding organs, with the exception of the bile
 duct

 -  No imaging evidence of metastatic disease or lymphadenopathy (lymph nodes
 greater than 1 cm and/or appearance suspicious for an advanced lesion by
 imaging criteria)

 -  Has a family history of pancreatic cancer and is considered to be an at-risk
 individual for the disease (i.e., member of a family with 2 or more individuals
 with pancreatic cancer)

 -  Control participants must meet 1 of the following criteria:

 -  Chronic pancreatitis OR history of exocrine insufficiency meeting the following
 criteria:

 -  At least 2 of the following criteria are met (unless patient has a history
 of pancreatic exocrine insufficiency in which case only 1 criterion must be
 met):

 -  Abdominal ultrasound that is consistent with chronic pancreatitis by
 standard radiological criteria (i.e., echogenic foci in the parenchyma,
 large or small cavities, calcifications, or dilated pancreatic duct)

 -  Abdominal CT scan consistent with chronic pancreatitis by standard
 radiological criteria (i.e., calcifications, dilated pancreatic duct,
 irregular contour of the gland, or cystic lesions)

 -  Endoscopic retrograde cholangiopancreatography exam consistent with
 chronic pancreatitis by standard radiological criteria (i.e., dilated
 tortuous main pancreatic duct with irregular secondary branches or
 intraductal calculi)

 -  Endoscopic ultrasound consistent with chronic pancreatitis by standard
 radiological criteria (i.e., echogenic foci, focal regions of decreased
 echogenicity, or pancreatic ductal changes)

 -  Pancreatic calcifications identified on plain film of the abdomen

 -  Must have an imaging study of the pancreas within 3 months of study
 enrollment that does not suggest a pancreatic mass

 -  Stable clinical history over the past year with no suspicion for cancer due
 to weight loss, jaundice, or change in abdominal symptoms

 -  No family history of pancreatic cancer

 -  Acute biliary obstruction (stones) including jaundice of benign etiology meeting
 the following criteria:

 -  Elevation of serum bilirubin level greater than 2.0 mg/dL

 -  Dilated extrahepatic biliary systems demonstrated on US, MRI, or CT scan

 -  Blood sample available within 72 hours of admission and prior to any
 corrective intervention

 -  Biliary obstruction must be of benign etiology such as common bile duct
 stone or benign biliary stricture

 -  Must have complete imaging study performed of the pancreas that does not
 suggest a pancreatic cancer (i.e., discrete mass lesion)

 -  No family history of pancreatic cancer

 -  Healthy control meeting the following criteria:

 -  Age, race, and sex-matched to qualified pancreatic cancer cases

 -  No family history of pancreatic cancer

 -  No personal history of acute pancreatitis or biliary obstruction (stones)
 including jaundice of benign etiology

 -  No concurrent abdominal pain

 -  No concurrent unexplained weight loss

 PATIENT CHARACTERISTICS:

 -  No prior malignancy, except nonmelanoma skin cancer, for 10 years

 PRIOR CONCURRENT THERAPY:

 -  See Disease Characteristics

 -  No prior preoperative chemoradiotherapy (neoadjuvant)