Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer and Their First-Degree Relatives
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 2250 |
| Study Start Date: | July 2008 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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Genetic: DNA analysis
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- Recontacting previously recruited Diet and Prostate Cancer Risk study participants; cases and biopsy negative controls
- Prospective recruitment of men referred for a prostate biopsy to the Portland VA urology clinic
- Men from the public sector who learn about our study and would like to participate
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
- Prior diagnosis of prostate cancer or negative prostate biopsy AND previously participated in Dr. Shannon's Diet and Prostate Cancer Risk study and consented to future studies (proband)
- Referred to the Portland VA Medical Center urology clinic for a prostate biopsy (proband)
First-degree relative (e.g., sibling, parent, or offspring) of a proband
- Introduced to this study by a proband OR found to be related to a proband who is part of a homogenous high-risk subgroup after completion of the family history of cancer analysis
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations| United States, Oregon | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Jackilen Shannon, PhD | Department of Veterans Affairs |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jackilen Shannon, Staff Scientist, Portland VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT01013129 History of Changes |
| Other Study ID Numbers: | CDR0000648179, VAMC-OR-M1736, CPC-07129-L |
| Study First Received: | November 11, 2009 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Portland VA Medical Center:
|
hereditary prostate cancer prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013