A Registry for Hereditary Cancer Risk Assessment and Genetic Testing
1 other identifier
observational
255
1 country
10
Brief Summary
This prospective registry will evaluate the feasibility and impact of implementing standard cancer family history review and guideline-aligned genetic testing for men diagnosed with Prostate Cancer in community urology practices nationwide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2019
CompletedFirst Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedNovember 5, 2020
November 1, 2020
1.6 years
June 26, 2019
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To see how practical it would be to integrate a standard hereditary cancer risk assessment, patient counseling and genetic testing process into the community urology practice setting.
To see how practical it would be to integrate a standard hereditary cancer risk assessment , patient counseling and genetic testing process into the community urology practice setting. Also to evaluate the impact of the integrated process on provider and patient satisfaction. This registry will gather information to evaluate the feasibility of HCRA and genetic testing process integration in the Urology community practice setting. Analysis of the registry will compare historical pre-process integration data with post-integration data from the same providers within participating community Urology practices.
18 weeks per site
Secondary Outcomes (1)
To see what the proportion of community urology patients with PrCa is who complete each component of the HCRA, patient counseling and genetic testing process.
18 weeks
Eligibility Criteria
Prostate Cancer patients, at least 18 years or older, who meet NCCN guidelines and eligibility criteria, who have a scheduled set appointment at Community Urology practices.
You may qualify if:
- Years of age or older at time of enrollment
- Affected with Prostate Cancer (newly or previously diagnosed patients).
- Presents for a medical care visit and meets eligibility criteria for hereditary cancer genetic testing, based on personal and family cancer history and NCCN Practice Guidelines in Oncology (Prostate Cancer)
- Able to understand informed consent and agrees to participate in the registry.
You may not qualify if:
- Minors (younger than 18 years of age)
- Have had previous genetic testing for Hereditary Breast and Ovarian Cancer or Lynch Syndrome, or have previously undergone hereditary multi-gene, pan-cancer, or panel testing.
- Unable to provide routine clinical informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Urology Associates of Central California
Fresno, California, 93720, United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410, United States
Comprehensive Urology
Royal Oak, Michigan, 48073, United States
Comprehensive Urology
Waterford, Michigan, 48328, United States
Associated Medical Professionals of New York
Syracuse, New York, 13210, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Biospecimen
Blood sample required for myRisk test
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neal Shore, MD
Carolina Urologic Research Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2019
First Posted
July 10, 2019
Study Start
March 6, 2019
Primary Completion
October 21, 2020
Study Completion
October 30, 2020
Last Updated
November 5, 2020
Record last verified: 2020-11