Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer

Completed

• Conditions: Hereditary Prostate Cancer; Prostate Cancer
• Interventions: 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

• Registration Number: NCT01013129
• Lead Sponsor: Portland VA Medical Center

Brief Summary

RATIONALE: Gathering information about genetic and environmental factors may help doctors learn more about a person's risk for developing prostate cancer.

PURPOSE: This research project is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer.

Detailed Description

OBJECTIVES:

* To determine the association between variation in genes involved in ROS detoxification, oxidative stress response, and prostate cancer risk.

* To determine the association between fatty acid levels 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. Medical records of probands are reviewed for demographics, history and course of disease, and clinical laboratory test results.

All probands completed 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 was 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 750 participants will be accrued for this study.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-11
• Study First Posted: 2009-11-13
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 748

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Probands	polymorphism analysis	-
Probands	study of high risk factors	-
Probands	evaluation of cancer risk factors	-
Probands	laboratory biomarker analysis	-
Probands	DNA analysis	-
Probands	medical chart review	-
Probands	questionnaire administration	-

Primary Outcome Measures

Name	Time	Method
Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk	through study completion; 1 day	Using saliva samples, we conducted analysis on probands' oxidative stress pathway genes and whether these were associated with prostate cancer risk.
Association between blood fatty acids and prostate cancer risk	through study completion; 1 day	Using blood samples, we conducted analysis on probands' fatty acid level and whether these were associated with prostate cancer risk.

Trial Locations

Locations (1)

Veterans Affairs Medical Center - Portland; 🇺🇸 Portland, Oregon, United States