Pancreatic Adenocarcinoma Gene Environment Risk Study (PAGER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00912717
First received: June 1, 2009
Last updated: May 1, 2015
Last verified: May 2015
  Purpose

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
Pancreatic Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and urine specimens


Estimated Enrollment: 10000
Study Start Date: January 2004
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic Cancer
individuals who have been diagnosed with pancreatic cancer
Unaffected
individuals who have not been diagnosed with pancreatic cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Randall Brand, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00912717     History of Changes
Other Study ID Numbers: PRO07030072
Study First Received: June 1, 2009
Last Updated: May 1, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 02, 2015