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OpenTrials
Completed

NCT Number: NCT01013129

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

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.

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Key information

Conditions

Hereditary Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostate cancer, familial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year–120 year

Sex eligibility

Male

Study type

Observational

Primary location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

DNA analysis

Genetic

saliva samples will be collected from men (probands) who join the study.

polymorphism analysis

Genetic

we will genotype DNA samples (buccal) from all probands and conduct a traditional case-control analysis

laboratory biomarker analysis

Other

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

medical chart review

Other

PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis

Questionnaire Administration

Other

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

evaluation of cancer risk factors

Procedure

pathology reports will be reviewed for probands whose prostate biopsies reveal cancer; these factors will be evaluated for cancer risk factors

study of high risk factors

Procedure

prostate biopsy pathology reports will be reviewed for high risk factors

Primary outcomes

  1. Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk

    Time frame: 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.

  2. Association between blood fatty acids and prostate cancer risk

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Portland VA Medical Center

Fed

Registry information

Official study title

Genetic Susceptibility, Environment & Prostate Cancer Risk

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 13, 2009
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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