Genetic Evaluation of Men (GEM)
- Conditions
- Prostate Cancer
- Interventions
- Other: GEM Registry
- Registration Number
- NCT03076242
- 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
- Men with a personal history of prostate cancer
- Unaffected males who are at higher risk for prostate cancer
- Age < 18 years
- Mental or cognitive impairment that interferes with ability to provide informed consent
- Social circumstances that may impair the ability to follow through with study or provide informed consent (such as homelessness, drug/alcohol dependence, etc.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gem Registry GEM Registry Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer
- Primary Outcome Measures
Name Time Method Genetic and genomic sequencing Three years Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk
Family cancer history collection Three 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 bank Three 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 collection Three 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-up Three years Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.
- Secondary Outcome Measures
Name Time Method
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