Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations

Completed

• Conditions: Prostate Cancer
• Interventions: Other: DECIPHER Questionnaire

• Registration Number: NCT02020876
• Lead Sponsor: GenomeDx Biosciences Corp

Brief Summary

This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher

Detailed Description

The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-01
• Status Verified: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-25
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Practicing urologic surgeons	DECIPHER Questionnaire	Performing at least 60 radical prostate surgeries annually

Primary Outcome Measures

Name	Time	Method
Change in treatment recommendation	1.5 years	To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP).; This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test.

Secondary Outcome Measures

Name	Time	Method
Urologist's perception regarding the utility of the Decipher	1.5 years	* Changes in Urologists expressed level of confidence in the treatment recommendation as measured by the response to item 4a in the eCRF survey.; * Urologist's perception regarding the utility of the Decipher test as measured by the responses to question 4b and 38b and 38c in the eCRF survey.; * Agreement in treatment recommendation

Trial Locations

Locations (1)

GenomeDx Bioscience Inc.; 🇺🇸 San Diego, California, United States