Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer and Their First-Degree Relatives
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|ClinicalTrials.gov Identifier: NCT01013129|
Recruitment Status : Unknown
Verified February 2013 by Jackilen Shannon, Portland VA Medical Center.
Recruitment status was: Active, not recruiting
First Posted : November 13, 2009
Last Update Posted : February 22, 2013
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.
|Condition or disease||Intervention/treatment|
|Hereditary Prostate Cancer 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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||2250 participants|
|Observational Model:||Case Control|
|Official Title:||Genetic Susceptibility, Environment & Prostate Cancer Risk|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2012|
- Genetic: DNA analysis
saliva samples will be collected from men (probands) who join the study as well as from first degree relatives who join the study
- Genetic: polymorphism analysis
we will genotype DNA samples (buccal) from all probands and conduct a traditional case-control analysis
- Other: laboratory biomarker analysis
10ml blood specimen will be obtained and processed (on probands locally-consented and/or those who have an appointment at the VA in Portland, Oregon) to allow for analyses of erythrocyte fatty acids and future nutrient and DNA analyses
- Other: medical chart review
PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis
- Other: questionnaire administration
probands are asked to complete questionnaires on 1) family history of cancer, 2) diet history over the past year, 3) employment environment and risk factors and/or 4) changes to diet, medications since enrollment in originating case control study
- Procedure: evaluation of cancer risk factors
pathology reports will be reviewed for probands whose prostate biopsies reveal cancer; these factors will be evaluated for cancer risk factors
- Procedure: study of high risk factors
prostate biopsy pathology reports will be reviewed for high risk factors
- Degree of familial aggregation for prostate cancer [ Time Frame: 4th quarter - 2012 ]
- Association between genetic variations, mitochondrial DNA damage, and prostate cancer risk [ Time Frame: 4th quarter - 2012 ]
- Association between dietary intake of ω-3 fatty acids and prostate cancer risk [ Time Frame: 4th quarter - 2012 ]
- Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk [ Time Frame: 4th quarter - 2012 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|