The Pancreatic Adenocarcinoma Gene Environment Risk Study - A Study of Patients at Risk or Having Pancreatic Disease (PAGER)
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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 |
- 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. 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. 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 |
Diagnosis with pancreatic cancer
Unaffected family members of those with pancreatic cancer
Unaffected individuals with no family history
Inclusion Criteria:
Subjects with a histologically confirmed or CT scan confirmed diagnosis of pancreatic adenocarcinoma.
OR
Subjects with an abnormal abdominal imaging study (CT, MRI, MRCP, EUS).
OR
- Control subjects with a clinical diagnosis of a pancreas, liver or intestinal condition.
- Control subjects being evaluated for non-pancreatic malignancies.
- Any member of a high-risk cancer family.
- Volunteers without any of the above conditions (healthy controls).
- Willingness to participate in the study.
- Eligibility is not dependent on participation of other members of the family including a spouse.
Exclusion Criteria:
- Under the age of 18 years.
- Unable to give informed consent.
Contacts and Locations| Contact: Sheila Solomon, MS | solomonsr@upmc.edu | |
| Contact: Megan Hendricks, RN | hendricksma@upmc.edu |
| United States, Pennsylvania | |
| 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 | |
| UPMC Hillman Cancer Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 152321 | |
| Contact: Sheila Solomon solomonsr@upmc.edu | |
| Contact: Megan Hendricks, RN hendricksma@upmc.edu | |
| 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 Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Diseases Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013