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Genetic Evaluation of Men (GEM)

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ClinicalTrials.gov Identifier: NCT03076242
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment
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 Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Genetic Evaluation of Men (GEM)
Actual Study Start Date : October 23, 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076242


Contacts
Contact: Giri Veda, M.D. 215-503-5285

Locations
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Mark Sundermeyer, MD    215-481-2400      
Principal Investigator: Mark Sundermeyer, MD         
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Veda Giri, M.D.    215-503-5285      
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Elias Obeid, MD, MPH    888-369-2427      
Principal Investigator: Elias Obeid, MD, MPH         
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

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03076242     History of Changes
Other Study ID Numbers: 14S.546
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No