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PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05447637
Recruitment Status : Completed
First Posted : July 7, 2022
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
Invitae Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Diagnostic Test: Invitae multi-cancer gene panel

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Individuals who meet NCCN Testing Criteria Diagnostic Test: Invitae multi-cancer gene panel
Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

Individuals who do not meet NCCN Testing Criteria Diagnostic Test: Invitae multi-cancer gene panel
Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.




Primary Outcome Measures :
  1. Diagnostic yield of pathogenic and likely pathogenic genes in the patient population [ Time Frame: to be assessed at baseline only ]
    Identify the diagnostic yield of pathogenic/likely pathogenic variants in known cancer syndrome genes in patients with prostate cancer, using the Invitae 84 gene multi-cancer panel. These rates will be compared between the two cohorts.


Secondary Outcome Measures :
  1. Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants [ Time Frame: at baseline only ]
    Compare rates of pathogenic / likely pathogenic variants found in both cohorts after testing using the Invitae 84 gene multi cancer panel.

  2. Evaluate the impact of genetic test results on clinical management decisions [ Time Frame: 60-90 days post test results received. ]
    Post-Test surveys for patients and the clinician report form will assess whether changes to clinical management were made as a result of the test results.


Biospecimen Retention:   None Retained
Blood samples provided for clinical genetic testing that include DNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men who have a diagnosis of prostate cancer who have not previously undergone testing for multi-gene hereditary cancer risk.
Criteria

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

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): NCT05447637


Locations
Show Show 19 study locations
Sponsors and Collaborators
Invitae Corporation
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Responsible Party: Invitae Corporation
ClinicalTrials.gov Identifier: NCT05447637    
Other Study ID Numbers: INVPC-1000
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases