- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015102
A Registry for Hereditary Cancer Risk Assessment and Genetic Testing
November 3, 2020 updated by: Myriad Genetic Laboratories, Inc.
A Registry for Hereditary Cancer Risk Assessment and Genetic Testing Among Men With Prostate Cancer in the Community Urology Practice Setting
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Genes linked to hereditary cancer syndromes have been associated with increased risk for prostate cancer (PrCa), earlier disease onset and increased disease aggressiveness.1,2
Ascertaining family cancer history and hereditary risk in men diagnosed with PrCa can help inform medical management decisions.
Recently published National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prostate Cancer (v3.2018)3 and Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019)4 as well as the American Urological Association Guideline for Clinically Localized Prostate Cancer (2017)5 recommend appropriate counseling and genetic testing for men who are at increased hereditary cancer risk, based upon personal or family history.
Genetic testing for patients with metastatic prostate cancer is now standard of care per NCCN Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019) guidelines4.
NCCN Prostate Cancer Guidelines (v3.2018)3 recommend obtaining a cancer-focused family history at diagnosis and consideration of germline genetic testing in multiple risk groups.
Community urology practices can support guideline-aligned care by performing routine hereditary cancer risk assessment (HCRA), patient counseling and, when appropriate, genetic testing.
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 PrCa in community urology practices nationwide.
Study Type
Observational
Enrollment (Actual)
255
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Arkansas Urology
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California
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Fresno, California, United States, 93720
- Urology Associates of Central California
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Indiana
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Merrillville, Indiana, United States, 46410
- Urologic Specialists of Northwest Indiana
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Michigan
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Royal Oak, Michigan, United States, 48073
- Comprehensive Urology
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Waterford, Michigan, United States, 48328
- Comprehensive Urology
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New York
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Syracuse, New York, United States, 13210
- Associated Medical Professionals of New York
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North Carolina
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Raleigh, North Carolina, United States, 27612
- Associated Urologists of North Carolina
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Oregon
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Springfield, Oregon, United States, 97477
- Oregon Urology Institute
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, United States, 19004
- MidLantic Urology
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 18 weeks per site
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 18 weeks
|
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.
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Neal Shore, MD, Carolina Urologic Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2019
Primary Completion (Actual)
October 21, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
June 26, 2019
First Submitted That Met QC Criteria
July 9, 2019
First Posted (Actual)
July 10, 2019
Study Record Updates
Last Update Posted (Actual)
November 5, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URO-012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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