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Spots Global Cancer Trial Database for Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists

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Trial Identification

Brief Title: Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations for Radiation Oncologists

Official Title: GenomeDx Decipher Test for Metastatic Disease Prognosis in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Radiation Oncologist' Treatment Recommendations?

Study ID: NCT02034812

Conditions

Prostate Cancer

Study Description

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

Detailed Description: Patient cases were selected using existing data generated from patient specimens collected in a separate IRB approved protocol, in which pathological specimens were tested to generate a test result for comparison to outcomes. Those test results are presented in this study, but not the individual patient outcomes. Physicians participating in this current study did not provide care for any of the subjects in the previous study. Cases are presented to physicians in a randomized order and in a form that prevents the patients from being identified, directly or indirectly. High risk patient cases were selected to reflect a range of clinicopathological variables and were further stratified based on the Decipher predicted probability of developing metastasis 5 years after RP and 3 years after BCR (as shown in the table below). High (low) Decipher (GC) risk was defined as a 5- or 3-year predicted probability of metastasis greater (less) than 6% for the adjuvant setting and greater (less) than 18% for the salvage setting.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Brigham and Women's Hospital, Boston, Massachusetts, United States

Contact Details

Name: Paul L. Nguyen, MD

Affiliation: Dana-Farber Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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