Clinical trial NCT03076242: Genetic Evaluation of Men (GEM)
Official title: Genetic Evaluation of Men (GEM)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Myriad Genetics, Inc.
First posted: 2017-03-10
Enrollment: 595
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

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.

Eligibility 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.)

Primary outcomes:
measure: Family cancer history collection
timeFrame: Three years
measure: Behavioral measure collection
timeFrame: Three years
measure: Biospecimen bank
timeFrame: Three years
measure: Genetic and genomic sequencing
timeFrame: Three years
measure: Participant follow-up
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Giri Veda, M.D.
role: PRINCIPAL_INVESTIGATOR
References: