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Pancreatic Adenocarcinoma Gene Environment Risk Study (PAGER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00912717
Recruitment Status : Recruiting
First Posted : June 3, 2009
Last Update Posted : July 24, 2017
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh

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 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

Pancreatic Cancer
individuals who have been diagnosed with pancreatic cancer
individuals who have not been diagnosed with pancreatic cancer

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

Information from the National Library of Medicine

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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)

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

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 identifier (NCT number): NCT00912717

Contact: Randall E Brand, MD 412-623-3105
Contact: Beth Dudley, MS, MPH, CGC 412-623-3105

United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Randall E Brand, MD    412-623-3105   
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Randall E Brand, MD University of Pittsburgh

Responsible Party: Randall Brand, M.D., University of Pittsburgh 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
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases