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A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
This registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. It will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.
This registry will enroll men with prostate cancer who have done multi-gene testing for their cancer. Patients will be enrolled into two cohorts, one for individuals who meet current NCCN testing guidelines, and one for individuals who do not meet current NCCN guidelines. The main goal of this Registry is to assess whether nationally developed guidelines used to select patients for hereditary testing are adequate to identify all patients with prostate cancer who may benefit from testing. Patients will completed a post-test survey regarding their testing experience and clinicians will be asked to provide additional medical records review information via the Clinician Report Form.
Age
18 - 90 years
Sex
MALE
Healthy Volunteers
No
Genesis Healthcare Partners
San Diego, California, United States
Invitae
San Francisco, California, United States
Department of Bioengineering and Therapeutic Sciences, University of California San Francisco
San Francisco, California, United States
Volunteer Faculty, University of California San Francisco
San Francisco, California, United States
Colorado Urology
Lakewood, Colorado, United States
Advanced Urology Institute
St. Petersburg, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
TGH Cancer Institute
Tampa, Florida, United States
North Georgia Urology
Dalton, Georgia, United States
Associated Urological Specialists
Chicago Ridge, Illinois, United States
Start Date
November 1, 2019
Primary Completion Date
July 1, 2021
Completion Date
May 31, 2022
Last Updated
July 7, 2022
1,000
ACTUAL participants
Invitae multi-cancer gene panel
DIAGNOSTIC_TEST
Lead Sponsor
Invitae Corporation
NCT04550494
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465