Pancreatic Cancer Genetic Epidemiology (PACGENE) Study

Official Title: “Pancreatic Cancer Genetic Epidemiology (PACGENE) Study”

The goal of this research study is to investigate the role of genes that may point to a higher risk of developing pancreatic cancer.

Objectives:

Our study is part of a multicenter, multidisciplinary Pancreatic Cancer Genetic Epidemiology (PACGENE) consortium to identify susceptibility genes in high risk FPC pedigrees using cutting-edge genetic analysis methods.

1. To identify high risk pedigrees for genetic linkage analysis utilizing established pancreatic cancer family research resources. We will recruit and screen new pancreatic cancer patients over 5 years to accrue biospecimens, tumor tissues, and risk factor data (including family history) from available relevant family members of familial pancreatic cancer (FPC) pedigrees suitable for genetic linkage studies (those with 3 or more persons affected with pancreatic cancer and those providing expected lod score of 0.3 or higher.

2. To genotype informative individuals in high-risk FPC pedigrees with 400 evenly spaced markers (~ 10 centimorgan intervals) throughout the genome. We will also perform genotyping with genome-wide microsatellite markers.

3. To map a pancreatic cancer susceptibility gene(s) by genetic linkage analysis of the high-risk FPC pedigrees. We propose to use conventional parametric linkage strategies, but will also implement the latest methods that incorporate environmental covariates in the analysis.

Participants in this study will be part of a pancreatic cancer genetic epidemiology consortium (herein referred to as "PACGENE"), which includes researchers at these institutions: Mayo Clinic; Johns Hopkins University; Creighton University; University of Toronto Mount Sinai Hospital; Dana Farber; and Karmanos Cancer Institute. Participants have either been diagnosed with pancreatic cancer or are family members of pancreatic cancer patients.

Participants will be asked questions by a trained interviewer using an approved questionnaire. The topics will include demographic data (age, race, etc.), exposures, medical history data, family history of cancer and other conditions, and other lifestyle factors. It should take about 30-40 minutes to complete the questionnaire.

Participants in this study will also have about one and a half tablespoons of blood drawn.

Blood that is collected will only be used by researchers involved in this study. If obtaining a blood sample is not possible, the study staff will ask for a saliva sample using an ORAGENE kit. Neither participants nor their physicians will receive individual reports of this research. Results will not be placed in the participant's health records. All information will be kept confidential and used only for this research.

There is a rare chance that a research team member could be accidentally exposed to your blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be used for these tests instead. You will be told that your blood is being tested and the results of your test. Researchers will ask how you would like to receive the results, such as by phone or certified letter. The test results and your name, address, date of birth, and sex will be recorded in the confidential M. D. Anderson medical records.

If you test positive for hepatitis or HIV, the test results and your name, address, date of birth, and sex will be shared with appropriate health authorities as required by law. You will also be given a list of places in your area so that you can receive further testing and treatment.

For the protection of your privacy, the study staff has obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify you, except as explained below.

The certificate cannot be used to resist a demand for information from personnel of the United State Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the certificate to withhold that information.

This is an investigational study. This study will include a total of 1,000 participants recruited at M. D. Anderson.

Intervention(s) in this Clinical Trial

• Behavioral: Questionnaire
  • Questionnaire taking about 30-40 minutes to complete.

Arms, Groups and Cohorts in this Clinical Trial

• : Questionnaire
  • Pancreatic cancer patients or family member.

Primary Measures

• Identification of susceptibility genes in high risk familial pancreatic cancer (FPC) pedigrees using cutting-edge genetic analysis methods
  • Time Frame: 8 Years
    Safety Issue?: No

Inclusion Criteria:

• An effected or uneffected member of a family, age 18 or older, that has two or more reported pancreatic cancers in the family.

Exclusion Criteria:

• Cases under age 18.
• Relatives of pancreatic cancer cases under age 18.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: M.D. Anderson Cancer Center Other

Overall Clinical Trial Officials and Contacts

Qingyi Wei, MD, PHD, MS Principal Investigator M.D. Anderson Cancer Center  

Overall Contact: Qingyi Wei, MD, PHD, MS 713-794-5264 

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00526578

Study ID Number: ID02-139

ClinicalTrials.gov Identifier: NCT00526578

Health Authority: United States: Institutional Review Board

MD Anderson Cancer Cancer