Genetic Evaluation of Men (GEM)

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03076242
• Collaborator: Myriad Genetics, Inc. (Industry)
• Enrollment: 595
• Locations: 3
• Anticipated Duration (Months): 80.3
• Patients Per Site: 198.3
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: GEM Registry

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 595 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Genetic Evaluation of Men (GEM)
• Actual Study Start Date: Oct 23, 2014
• Actual Primary Completion Date: Jan 15, 2019
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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

4. Genetic and genomic sequencing [Three years]

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

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
2	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
3	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111

Sponsors and Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University
• Myriad Genetics, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

Publications

None provided.

• Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT03076242
• Other Study ID Numbers: 14S.546
• First Posted: Mar 10, 2017
• Last Update Posted: Feb 11, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Feb 11, 2021