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The Pancreatic Adenocarcinoma Gene Environment Risk Study -A Prospective Cohort Study of Patients at Risk or Having Pancreatic Disease


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

The Pancreatic Adenocarcinoma Gene Environment Risk Study -A Prospective Cohort Study of Patients at Risk or Having Pancreatic Disease


After informed consent, demographic and epidemiological data will be collected from the
PAGER questionnaires. Blood and urine for DNA and biomarkers will be obtained from at least
1000 individuals with pancreatic cancer, 1000 high-risk subjects, 500 spouse (environment)
controls and 500 population controls. Samples will be collected using EDRN SOPS, split into
multiple storage vials, and stored at -80° C. The samples will then be used for experiments
to address the specific aims of this study.


Inclusion Criteria:



1. Subjects with a histologically confirmed or CT scan confirmed diagnosis of pancreatic
adenocarcinoma.

OR

2. Subjects with an abnormal abdominal imaging study (CT, MRI, MRCP, EUS).

OR

3. Control subjects with a clinical diagnosis of a pancreas, liver or intestinal
condition.

4. Control subjects being evaluated for non-pancreatic malignancies.

5. Any member of a high-risk cancer family.

6. Volunteers without any of the above conditions (healthy controls).

7. Willingness to participate in the study.

8. Eligibility is not dependent on participation of other members of the family
including a spouse.

Exclusion Criteria:

1. Under the age of 18 years.

2. Unable to give informed consent.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Randall Brand, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

PRO07030072

NCT ID:

NCT00912717

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • Unaffected individuals
  • unaffected family members of individuals affected by pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Diseases
  • Pancreatic Neoplasms

Name

Location

UPMC Hillman Cancer CenterPittsburgh, Pennsylvania  15232
UPMC Presbyterian HospitalPittsburgh, Pennsylvania  15213
UPMC Shadyside HospitalPittsburgh, Pennsylvania  15232