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

N/ACompletedNCT02020876

GenomeDx Biosciences Corp21 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

DECIPHER QuestionnaireOTHER

Participants are asked to complete a questionnaire to assess the impact of Decipher on physicians' treatment recommendation. All participants use the same data collection instrument. Each participant opinion is collected based on a random selection of cases.

Eligibility

Sex: MALEHealthy volunteers:

Medical Language ↔ Plain English

Criteria (Participant enrollment) Inclusion Criteria Study participants: 1. Practicing board-certified urologic surgeons 2. Performing at least 40 radical prostate surgeries annually Exclusion Criteria Study Participants: (1) Did not meet the inclusion criteria Criteria (Case selection) Inclusion Criteria Case File: Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as: Pathological Gleason score \>= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery Exclusion Criteria Case File: Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)

Locations (1)

GenomeDx Bioscience Inc.

San Diego, California, United States

Outcomes

Primary Outcomes

Change in treatment recommendation

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.

Time frame: 1.5 years

Secondary Outcomes

Urologist's perception regarding the utility of the Decipher

* 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

Time frame: 1.5 years

Data from ClinicalTrials.gov

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