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A Registry for Hereditary Cancer Risk Assessment and Genetic Testing

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ClinicalTrials.gov Identifier: NCT04015102
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Carolina Urologic Research Center
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

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.

Condition or disease
Prostate Cancer

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Registry for Hereditary Cancer Risk Assessment and Genetic Testing Among Men With Prostate Cancer in the Community Urology Practice Setting
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : March 6, 2022
Estimated Study Completion Date : July 6, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  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. [ 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.


Biospecimen Retention:   Samples With DNA
Blood sample required for myRisk test


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
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.
Criteria

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.

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): NCT04015102


Contacts
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Contact: Thaylon Davis 801-505-5109 tdavis@myriad.com
Contact: Megan Roberts 801-746-6564 mastle@myriad.com

Locations
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United States, Arkansas
Arkansas Urology Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Katie O'Brien       katie@arkansasurology.com   
Principal Investigator: Richard D'Anna, MD         
United States, Indiana
Urologic Specialists of Northwest Indiana Recruiting
Merrillville, Indiana, United States, 46410
Contact: LeeAnn Shea       lshea@urologic-specialists.com   
Principal Investigator: Manoj V. Rao, MD         
United States, North Carolina
Associated Urologists of North Carolina Not yet recruiting
Raleigh, North Carolina, United States, 27612
Contact: Kip Moffett       kmoffett@auncurology.com   
Contact: Glenna Gourley       ggourley@auncurology.com   
Principal Investigator: Mark W Jalkut, MD         
United States, Pennsylvania
MidLantic Urology Not yet recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Contact: Kelly Liberatore    610-667-0458    kliberatore@ucsepa.com   
Principal Investigator: Laurence H Belkoff, MD         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Laura Prince       lprince@curcmb.com   
Principal Investigator: Neal Shore, MD         
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Carolina Urologic Research Center
Investigators
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Principal Investigator: Neal Shore, MD Carolina Urologic Research Center

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Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT04015102     History of Changes
Other Study ID Numbers: URO-012
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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

Keywords provided by Myriad Genetic Laboratories, Inc.:
Prostate Cancer Patients
myRisk genetic testing

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases