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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.
 
ClinicalTrials.gov Identifier: NCT00912717
Recruitment Status : Recruiting
First Posted : June 3, 2009
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh

Tracking Information
First Submitted Date June 1, 2009
First Posted Date June 3, 2009
Last Update Posted Date August 6, 2019
Study Start Date January 2004
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pancreatic Adenocarcinoma Gene Environment Risk Study
Official Title The Pancreatic Adenocarcinoma Gene Environment Risk Study -A Prospective Cohort Study of Patients at Risk or Having Pancreatic Disease
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine specimens
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)
Condition Pancreatic Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Pancreatic Cancer
    individuals who have been diagnosed with pancreatic cancer
  • Unaffected
    individuals who have not been diagnosed with pancreatic cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 2, 2009)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Randall E Brand, MD 412-623-3105 brandre@upmc.edu
Contact: Beth Dudley, MS, MPH, CGC 412-623-3105 dudleyre@upmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00912717
Other Study ID Numbers PRO07030072
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Randall Brand, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Not Provided
Investigators
Principal Investigator: Randall E Brand, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date August 2019