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1) Development of the Pancreatic Cancer Collaborative Registry and Risk Assessment Models; 2) Pancreatic Cancer Pre-Validation Reference Set for Serum/Plasma Biomarkers; 3) Effects of Tobacco and Alcohol on Pancreatic Cancer; 4) Enhancing the Biomedical Computing Platform for Pancreatic Cancer Research


N/A
19 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

1) Development of the Pancreatic Cancer Collaborative Registry and Risk Assessment Models; 2) Pancreatic Cancer Pre-Validation Reference Set for Serum/Plasma Biomarkers; 3) Effects of Tobacco and Alcohol on Pancreatic Cancer; 4) Enhancing the Biomedical Computing Platform for Pancreatic Cancer Research


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.

- Establish an infrastructure with core data elements and standardized operating
procedures for specimen collection, processing, and storage for the EDRN Pancreatic
Cancer Working Group project to use as a resource for the development of biomarkers for
the early detection of pancreatic adenocarcinoma.

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.

Control participants provide blood samples and complete questionnaires at baseline. Clinical
data is collected annually.

PROJECTED ACCRUAL: A total of 60 patients per group (i.e., cancer cases, healthy controls,
acute biliary obstruction cases, and chronic pancreatitis cases) for a total of 240 patients
will be accrued for EDRN portion of this study. A total of ~5,000 patients will be accrued
to the PCCR portion of this study.

Inclusion Criteria


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)

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Development of integrated Biomedical Computing Tools

Outcome Description:

Ongoing Registry

Outcome Time Frame:

Yearly

Safety Issue:

No

Principal Investigator

Simon Sherman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

405-02

NCT ID:

NCT00661882

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680