Genetic Evaluation of Men (GEM)

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

595 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-23

Study Completion Date

2019-05-16

Brief Summary

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This is a prospective research registry and prospective genetic testing cohort study. The goal is to collect personal medical and cancer history data, family cancer data, exposure history, and biospecimens to support research focused on optimal genetic testing strategies for men with prostate cancer with the ultimate goal of informing national guidelines focused on genetic evaluation for prostate cancer.

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Detailed Description

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Objectives:

1. Collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility.
2. Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process.
3. Create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk.
4. Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk.
5. Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gem Registry

Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

GEM Registry

Intervention Type OTHER

Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

Interventions

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GEM Registry

Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Men with a personal history of prostate cancer
2. Unaffected males who are at higher risk for prostate cancer

Exclusion Criteria

1. Age \< 18 years
2. Mental or cognitive impairment that interferes with ability to provide informed consent
3. Social circumstances that may impair the ability to follow through with study or provide informed consent (such as homelessness, drug/alcohol dependence, etc.)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No