The Pancreatic Adenocarcinoma Gene Environment Risk Study - A Study of Patients at Risk or Having Pancreatic Disease (PAGER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00912717
First received: June 1, 2009
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

Early detection of precancerous lesions or very early cancers offers the best chance for curing cancer. Imaging of pancreatic masses by computed tomography (CT) scan, magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology is currently the most sensitive and specific method for early identification of pancreatic neoplasms. Unfortunately, current techniques require that the pancreatic mass is of a size when blood vessel invasion and metastasis have often already occurred. Thus, new approaches are needed to identify early pancreatic cancer before it is normally visible on imaging studies. Furthermore, the suspicion of pancreatic cancer can cause tremendous distress in patients, family members and their care givers, and lead to expensive and repeated evaluations and diagnostic procedures. Thus, new markers with high positive and negative predictive value are needed.

The investigators hypothesize that the most effective strategy to reduce the burden of pancreatic cancer is a systematic approach that utilizes new methods that stratify subjects from the general population by history (personal and/or family) or genetic tests into a high-risk cohort, then to screen patients at high risk with tests on blood, pancreatic juice or samples from fine needle aspiration of cystic or solid lesions for early detection, diagnosis or exclusion of pancreatic cancers or premalignant lesions (e.g., intraductal neoplasia (PanIN) lesions [1]). The investigators propose to identify new markers and develop a new test using biological samples and imaging technologies using complementary strategies.


Condition Intervention
Pancreatic Cancer
Biological: blood and urine specimen collection
Other: questionnaire
Biological: collection of biological waste

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
Groups/Cohorts Assigned Interventions
pancreatic cancer
subjects diagnosed with pancreatic cancer
Biological: blood and urine specimen collection

50 cc of blood and a one time urine specimen are collected at enrollment.

Subsequent blood samples : For affected individuals we will obtain subsequent 45cc blood samples for biomarkers during routine clinical visits at a frequency of once per month or as determined by their individual clinical course,for an indefinite period of time. For controls, 45cc blood samples will be obtained during routine clinical visits annually.

Other: questionnaire
questionnaire will be completed at enrollment
Biological: collection of biological waste
In cases where the subject is having a procedure, biological waste (material that is not needed for clinical care, eg., pancreatic cyst fluid) will also be collected and stored.
unaffected
subject with no diagnosis of pancreatic cancer
Biological: blood and urine specimen collection

50 cc of blood and a one time urine specimen are collected at enrollment.

Subsequent blood samples : For affected individuals we will obtain subsequent 45cc blood samples for biomarkers during routine clinical visits at a frequency of once per month or as determined by their individual clinical course,for an indefinite period of time. For controls, 45cc blood samples will be obtained during routine clinical visits annually.

Other: questionnaire
questionnaire will be completed at enrollment
Biological: collection of biological waste
In cases where the subject is having a procedure, biological waste (material that is not needed for clinical care, eg., pancreatic cyst fluid) will also be collected and stored.

Detailed Description:

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.

  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

Diagnosis with pancreatic cancer

Unaffected family members of those with pancreatic cancer

Unaffected individuals with no family history

Criteria

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.
  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: Sheila Solomon, MS solomonsr@upmc.edu
Contact: Megan Hendricks, RN hendricksma@upmc.edu

Locations
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 152321
Contact: Sheila Solomon       solomonsr@upmc.edu   
Contact: Megan Hendricks, RN       hendricksma@upmc.edu   
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sheila Solomon, MS       solomonsr@upmc.edu   
Contact: Megan Hendricks, RN       hendricksma@upmc.edu   
Principal Investigator: Randall Brand, MD         
Sub-Investigator: Jaideep Behari, MD         
Sub-Investigator: Kapil Chopra, MD         
Sub-Investigator: Scott Cooper, MD         
Sub-Investigator: Kenneth Fasanella, MD         
Sub-Investigator: Asif Khalid, MD         
Sub-Investigator: Kevin McGrath, MD         
Sub-Investigator: Stephen OKeefe, MD         
Sub-Investigator: Georgios Papachristou, MD         
Sub-Investigator: Adam Slivka, MD         
Sub-Investigator: Dhiraj Yadav, MD         
Sub-Investigator: David Whitcomb, MD         
UPMC Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Sheila Solomon       solomonsr@upmc.edu   
Contact: Megan Hendricks, RN       hendricksma@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Randall 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: January 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
pancreatic cancer
Unaffected individuals
unaffected family members of individuals affected by pancreatic cancer

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

ClinicalTrials.gov processed this record on October 21, 2014