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Pancreatic Adenocarcinoma Gene Environment Risk Study (PAGER)

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ClinicalTrials.gov Identifier: NCT00912717
Recruitment Status : Recruiting
First Posted : June 3, 2009
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh

Study Description
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Brief Summary:
After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Some participants may also be asked to provide a urine sample. Individuals undergoing procedures that require collection of biological samples for clinical purposes may have these samples saved for research purposes. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.

Condition or disease
Pancreatic Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Pancreatic Adenocarcinoma Gene Environment Risk Study -A Prospective Cohort Study of Patients at Risk or Having Pancreatic Disease
Study Start Date : January 2004
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Pancreatic Cancer
individuals who have been diagnosed with pancreatic cancer
Unaffected
individuals who have not been diagnosed with pancreatic cancer


Outcome Measures
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Primary Outcome Measures :
  1. The data will be used in cohort association studies. Endpoints will depend on the number of patients in the study and the number of markers that are being evaluated. [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Blood and urine specimens

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who are diagnosed with pancreatic cancer, who are undergoing a procedure to evaluate their pancreas, and who have a family history of pancreatic cancer are recruited during appointments at the University of Pittsburgh Medical Center (e.g. Pancreas Specialty Care Center, GI laboratory, Hereditary GI Program)
Criteria

Inclusion Criteria:

  • Histologically confirmed or CT confirmed diagnosis of pancreatic adenocarcinoma
  • Subjects with abnormal imaging study (CT, MRI, MRCP, EUS)
  • Control subjects with a clinical diagnosis of a pancreas, liver, or intestinal condition
  • Control subject with acute pancreatitis
  • Control subject with chronic pancreatitis
  • Control subject with biliary obstruction
  • Control subject with pancreatic cyst
  • Member of a high risk family (≥ 1 close relative with pancreatic cancer)
  • Healthy control (without any of the above conditions)

Exclusion Criteria:

  • Under the age of 18 years
  • Unable to give informed consent
  • Inability to travel to Pittsburgh for in-person enrollment
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912717


Contacts
Contact: Randall E Brand, MD 412-623-3105 brandre@upmc.edu
Contact: Beth Dudley, MS, MPH, CGC 412-623-3105 dudleyre@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Randall E Brand, MD    412-623-3105    brandre@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Randall E Brand, MD University of Pittsburgh
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Randall Brand, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00912717     History of Changes
Other Study ID Numbers: PRO07030072
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pancreatic Diseases
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases