PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

NCT ID: NCT05447637

Last Updated: 2022-07-07

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals who meet NCCN Testing Criteria

Invitae multi-cancer gene panel

Intervention Type DIAGNOSTIC_TEST

Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

Individuals who do not meet NCCN Testing Criteria

Invitae multi-cancer gene panel

Intervention Type DIAGNOSTIC_TEST

Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

Interventions

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Invitae multi-cancer gene panel

Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Men ages 18-90 who have been prescribed genetic testing as part of their clinical care
* Have prostate cancer at any stage, either actively under treatment or being followed who either: 1. meet NCCN criteria for testing or 2. do not meet NCCN criteria for testing
* Patients who are naive to clinical genetic testing for BRCA1/BRCA2 (single gene panel testing)

Exclusion Criteria

* Mental or cognitive impairment that interferes with ability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Invitae Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Genesis Healthcare Partners

San Diego, California, United States

Site Status

Invitae

San Francisco, California, United States

Site Status

Department of Bioengineering and Therapeutic Sciences, University of California San Francisco

San Francisco, California, United States

Site Status

Volunteer Faculty, University of California San Francisco

San Francisco, California, United States

Site Status

Colorado Urology

Lakewood, Colorado, United States

Site Status

Advanced Urology Institute

St. Petersburg, Florida, United States

Site Status

Florida Urology Partners

Tampa, Florida, United States

Site Status

TGH Cancer Institute

Tampa, Florida, United States

Site Status

North Georgia Urology

Dalton, Georgia, United States

Site Status

Associated Urological Specialists

Chicago Ridge, Illinois, United States

Site Status

University Urology Associates of New Jersey

Hamilton, New Jersey, United States

Site Status

Perlmutter Cancer Center, NYU Langone Health, New York

New York, New York, United States

Site Status

Associated Medical Professionals

Syracuse, New York, 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

Urology Associates, P.C.

Nashville, Tennessee, United States

Site Status

Urology Partners

Arlington, Texas, United States

Site Status

Urology Austin

Austin, Texas, United States

Site Status

Urosurgery Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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INVPC-1000

Identifier Type: -

Identifier Source: org_study_id

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