MedPath

Genetic Evaluation of Men (GEM)

Terminated
Conditions
Prostate Cancer
Interventions
Other: GEM Registry
Registration Number
NCT03076242
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Male
Target Recruitment
595
Inclusion Criteria
  1. Men with a personal history of prostate cancer
  2. Unaffected males who are at higher risk for prostate cancer
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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.)
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Gem RegistryGEM RegistryMen with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer
Primary Outcome Measures
NameTimeMethod
Genetic and genomic sequencingThree years

Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk

Family cancer history collectionThree years

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.

Biospecimen bankThree years

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

Behavioral measure collectionThree years

Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process

Participant follow-upThree years

Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Sidney Kimmel Cancer Center at Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Abington Memorial Hospital

🇺🇸

Abington, Pennsylvania, United States

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