Genetic Evaluation of Men (GEM)

Prostate Cancer Clinical Trial

Official title:

Genetic Evaluation of Men (GEM)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03076242
• Other study ID #: 14S.546
• Status: Terminated
• Start date: October 23, 2014
• Est. completion date: May 16, 2019

Study information

• Verified date: November 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 595
• Est. completion date: May 16, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• GEM Registry
Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	Myriad Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Thomas Jefferson University Hospital