Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Computer Tools for Improving Early Diagnosis and Treatment in Healthy Volunteers or Patients With Pancreatic Cancer or Who Are At Risk For Pancreatic Cancer or Who Have a Noncancer Pancreatic Disorder

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Natural history/Epidemiology, Tissue collection/Repository	Active	Not specified	NCI	UNMC-40502 405-02, NCT00661882

Objectives

1. Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and treatment of pancreatic cancer by using the power of computer and informatics sciences.
2. 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.
3. 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.
4. 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.
5. 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.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior preoperative chemoradiotherapy (neoadjuvant)

Patient Characteristics:

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

Expected Enrollment

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 this study.

Outcomes

Development of integrated Biomedical Computing Tools
Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data
Participation in the international pancreatic registry known as the PCCR by sharing information
Collection and banking of excess biological materials (i.e., pancreatic tissue, tumor tissue ,and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue), blood, and serum
Establishment of an infrastructure with core data elements and standardized operating procedures for specimen collection, processing, and storage

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.

Trial Contact Information

Trial Lead Organizations

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Simon Sherman, PhD, Principal investigator		Ph: 402-559-4238

U.S.A.
Nebraska
	Omaha
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465

Registry Information
Official Title		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
Trial Start Date		2003-02-06
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00661882
Date Submitted to PDQ		2007-12-17
Information Last Verified		2009-06-14
NCI Grant/Contract Number		CA36727, CA140940

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