Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer and Their First-Degree Relatives
Recruitment status was Active, not recruiting
RATIONALE: Gathering information about genetic and environmental factors may help doctors learn more about a person's risk for developing prostate cancer.
PURPOSE: This clinical trial is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer and their first-degree relatives.
Hereditary Prostate Cancer
Genetic: DNA analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review
Other: questionnaire administration
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Genetic Susceptibility, Environment & Prostate Cancer Risk|
- Degree of familial aggregation for prostate cancer [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]
- Association between genetic variations, mitochondrial DNA damage, and prostate cancer risk [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]
- Association between dietary intake of ω-3 fatty acids and prostate cancer risk [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]
- Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
10ml blood specimen drawn from probands consented in person at the Portland VA; saliva samples from all consented probands; saliva samples from first degree relatives
|Study Start Date:||July 2008|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Genetic: DNA analysis
- To evaluate the evidence of familial aggregation for prostate cancer and identify a homogenous subgroup of families with elevated likelihood of aggressive disease ("high familial risk") using a family case-control design.
- To determine if genetic variation in selected genes involved in reactive oxygen species (ROS) detoxification (e.g., glutathione and superoxide dismutase genes) and the oxidative stress response (e.g., NFE2) are independently or jointly associated with greater mitochondrial DNA damage and increased prostate cancer risk.
- To determine if dietary intake of ω-3 fatty acids alters the risk of prostate cancer.
- To determine the association between variation in genes involved in ROS detoxification, oxidative stress response, and prostate cancer risk.
OUTLINE: Probands undergo blood and saliva sample collection for fatty acid, DNA, and polymorphism analyses. Archived blood and tissue samples from probands who previously participated in Dr. Shannon's Diet and Prostate Cancer Risk study are also analyzed. First-degree relatives (FDRs) of probands found to be part of a homogenous high-risk subgroup undergo saliva sample collection for DNA analyses.
Medical records of probands are reviewed for demographics, history and course of disease, and clinical laboratory test results.
All probands and their FDRs complete the "Genetic Risk Easy Assessment Tool Family History of Cancer" and "Diet History and Environmental Risk Factor" questionnaires at baseline. If a proband previously participated on our Diet and Prostate Cancer Risk study, he is asked to complete the "Changes in Diet, Prescriptions, Supplementals and Herbal Remedies" questionnaire in addition to the "Genetic Risk Easy Assessment Tool Family History of Cancer" questionnaire at baseline for this study.
PROJECTED ACCRUAL: A total of 2,250 participants (750 probands and 1,500 first-degree relatives) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013129
|United States, Oregon|
|Veterans Affairs Medical Center - Portland|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Jackilen Shannon, PhD||VA Office of Research and Development|