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Genetic Evaluation of Men (GEM)

Genetic Evaluation of Men (GEM)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03076242
Enrollment
595
Registered
2017-03-10
Start date
2014-10-23
Completion date
2019-05-16
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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.

Detailed description

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.

Interventions

OTHERGEM Registry

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

Sponsors

Myriad Genetics, Inc.
CollaboratorINDUSTRY
Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Family cancer history collectionThree yearsCollect 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.
Behavioral measure collectionThree yearsCollect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process
Biospecimen bankThree yearsCreate 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
Genetic and genomic sequencingThree yearsPerform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk
Participant follow-upThree yearsDevelop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026