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Clinical Trials/NCT05470036
NCT05470036
Completed
Not Applicable

IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer

University of California, San Diego1 site in 1 country50 target enrollmentSeptember 27, 2022
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University of California, San Diego
Enrollment
50
Locations
1
Primary Endpoint
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.

Detailed Description

This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.

Registry
clinicaltrials.gov
Start Date
September 27, 2022
End Date
September 1, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rana Mckay

Associate Professor of Medicine and Urology

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • Men, age greater than or equal to 18 years of age.
  • Diagnosis of prostate cancer of any histology.
  • Must meet NCCN guidelines for germline testing

Exclusion Criteria

  • Have had prior germline testing.
  • Have somatic genetic testing that is positive for a possible germline variant.

Outcomes

Primary Outcomes

Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.

Time Frame: Within 1 year

Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.

Secondary Outcomes

  • Patient Baseline Knowledge of Germline Testing(Baseline)
  • Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing(Within 18 months)
  • Number of Participants With Pathogenic Germline Mutations(within 18 months)
  • Patient Knowledge of Germline Testing After the Educational Intervention.(within 18 months)

Study Sites (1)

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