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A Registry for Hereditary Cancer Risk Assessment and Genetic Testing

NCT ID: NCT04015102

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-06

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Carolina Urologic Research Center

OTHER

Sponsor Role collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Shore, MD

Role: PRINCIPAL_INVESTIGATOR

Carolina Urologic Research Center

Locations

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Arkansas Urology

Little Rock, Arkansas, United States

Site Status

Urology Associates of Central California

Fresno, California, United States

Site Status

Urologic Specialists of Northwest Indiana

Merrillville, Indiana, United States

Site Status

Comprehensive Urology

Royal Oak, Michigan, United States

Site Status

Comprehensive Urology

Waterford, Michigan, United States

Site Status

Associated Medical Professionals of New York

Syracuse, New York, United States

Site Status

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

Site Status

Oregon Urology Institute

Springfield, Oregon, United States

Site Status

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Site Status

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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URO-012

Identifier Type: -

Identifier Source: org_study_id