Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations (DECIDE)
|ClinicalTrials.gov Identifier: NCT02020876|
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: DECIPHER Questionnaire|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||GenomeDx Decipher Test for Metastatic Disease in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Physician Decision Making?|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||December 2013|
Practicing urologic surgeons
Performing at least 60 radical prostate surgeries annually
Other: DECIPHER Questionnaire
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.
- Change in treatment recommendation [ Time Frame: 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.
- Urologist's perception regarding the utility of the Decipher [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020876
|United States, California|
|GenomeDx Bioscience Inc.|
|San Diego, California, United States, 92121|
|Principal Investigator:||Elai Davicioni, pHd||GenomeDx Biosciences Inc.|
|Principal Investigator:||Badani Ketan, MD||Department of Urology, Columbia University, New York, NY USA|