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

NCT01013129 | Completed

• 3 other identifiers: CDR0000648179VAMC-OR-M1736CPC-07129-L
• Study Type: observational
• Target: 748
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Prostate Cancer; Prostate Cancer

Keywords

hereditary prostate cancer; prostate cancer

Outcome Measures

Primary Outcomes (2)

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

  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

  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

Study Arms (1)

Probands

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

Interventions

DNA analysis GENETIC

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

Probands

polymorphism analysis GENETIC

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

Probands

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

Probands

medical chart review OTHER

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

Probands

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

Probands

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

Probands

study of high risk factors PROCEDURE

prostate biopsy pathology reports will be reviewed for high risk factors

Probands

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Portland VA Medical Center: lead

Study Sites (1)

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

10ml blood specimen drawn from probands consented in person at the Portland VA; saliva samples from all consented probands (N = 748).

MeSH Terms

Conditions

Prostate cancer, familial; Prostatic Neoplasms

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Jackilen Shannon, PhD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Scientist

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: July 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

US (1)