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

Sponsor
Portland VA Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01013129
Collaborator
(none)
748
1
53
14.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

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 Design

Study Type:
Observational
Actual Enrollment :
748 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Genetic Susceptibility, Environment & Prostate Cancer Risk
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Probands

Genetic: DNA analysis
saliva samples will be collected from men (probands) 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 120 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Veterans Affairs Medical Center - Portland Portland Oregon United States 97239

Sponsors and Collaborators

  • Portland VA Medical Center

Investigators

  • Principal Investigator: Jackilen Shannon, PhD, Portland VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jackilen Shannon, Staff Scientist, Portland VA Medical Center
ClinicalTrials.gov Identifier:
NCT01013129
Other Study ID Numbers:
  • CDR0000648179
  • VAMC-OR-M1736
  • CPC-07129-L
First Posted:
Nov 13, 2009
Last Update Posted:
Nov 11, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Jackilen Shannon, Staff Scientist, Portland VA Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 11, 2021