Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer
NCT ID: NCT01013129
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
748 participants
OBSERVATIONAL
2008-07-31
2012-12-31
Brief Summary
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PURPOSE: This research project is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Probands
DNA analysis
saliva samples will be collected from men (probands) who join the study.
polymorphism analysis
we will genotype DNA samples (buccal) from all probands and conduct a traditional case-control analysis
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
medical chart review
PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis
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
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
study of high risk factors
prostate biopsy pathology reports will be reviewed for high risk factors
Interventions
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DNA analysis
saliva samples will be collected from men (probands) who join the study.
polymorphism analysis
we will genotype DNA samples (buccal) from all probands and conduct a traditional case-control analysis
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
medical chart review
PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis
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
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
study of high risk factors
prostate biopsy pathology reports will be reviewed for high risk factors
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
120 Years
MALE
Yes
Sponsors
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Portland VA Medical Center
FED
Responsible Party
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Jackilen Shannon
Staff Scientist
Principal Investigators
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Jackilen Shannon, PhD
Role: PRINCIPAL_INVESTIGATOR
Portland VA Medical Center
Locations
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Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
Countries
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Other Identifiers
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VAMC-OR-M1736
Identifier Type: -
Identifier Source: secondary_id
CPC-07129-L
Identifier Type: -
Identifier Source: secondary_id
CDR0000648179
Identifier Type: -
Identifier Source: org_study_id