Genetic Evaluation of Men (GEM)

April 28, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

595

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gem Registry
Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer
Other: GEM Registry
Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family cancer history collection
Time Frame: 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.
Three years
Behavioral measure collection
Time Frame: Three years
Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process
Three years
Biospecimen bank
Time Frame: 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
Three years
Genetic and genomic sequencing
Time Frame: Three years
Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk
Three years
Participant follow-up
Time Frame: Three years
Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Myriad Genetics, Inc.

Investigators

  • Principal Investigator: Giri Veda, M.D., Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2014

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

May 16, 2019

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14S.546
  • JT 6981 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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