Pancreatic Adenocarcinoma Gene Environment Risk Study (PAGER)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2016 by University of Pittsburgh
Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00912717
First received: June 1, 2009
Last updated: January 14, 2016
Last verified: January 2016
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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 (Adult, Senior) |
| 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
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
| 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: | January 14, 2016 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 27, 2016