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

November 9, 2021 updated by: Jackilen Shannon, Portland VA Medical Center

Genetic Susceptibility, Environment & Prostate Cancer Risk

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

748

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Veterans Affairs Medical Center - Portland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

  1. Recontacting previously recruited Diet and Prostate Cancer Risk study participants; cases and biopsy negative controls
  2. Prospective recruitment of men referred for a prostate biopsy to the Portland VA urology clinic
  3. Men from the public sector who learn about our study and would like to participate

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion; 1 day
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.
through study completion; 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portland VA Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 11, 2009

First Submitted That Met QC Criteria

November 11, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000648179
  • VAMC-OR-M1736
  • CPC-07129-L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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