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Clinical Trial Record

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Pancreatic Cancer Collaborative Registry

2003-02

2013-09-09

2013-09-09

379

Study Overview

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.

  • Pancreatic Cancer
  • OTHER: medical chart review
  • OTHER: questionnaire administration
  • OTHER: study of socioeconomic and demographic variables
  • PROCEDURE: biopsy
  • 0405-02-FB
  • 5T32CA009476 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2008-04-18  

N/A  

2023-08-31  

2008-04-18  

N/A  

2023-09-06  

2008-04-21  

N/A  

2023-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history dataOngoing registry.Yearly
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:
1

    Patients Participants Inclusion Criteria:
    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)

    • Patients Participants Exclusion Criteria:

  • No prior malignancy, except nonmelanoma skin cancer, for 10 years
  • No prior preoperative chemoradiotherapy (neoadjuvant)

    • Control participants Inclusion Criteria:
    Must meet 1 of the following criteria:

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

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

    • Control Participants Exclusion Criteria:

  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • National Cancer Institute (NCI)
  • PRINCIPAL_INVESTIGATOR: Quan Ly, MD, University of Nebraska

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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