Multi-site Decision Impact Study for Decipher (ASSESS-D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02034825|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: Decipher Questionnaire|
The clinical utility of Decipher will be evaluated at two time-points:
- Post RP - within 6 months after surgery
- PSA rise - defined as PSA detectable and rising on 2 or more subsequent determinations
Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively. The resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . All study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome.
The design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. Patient cases will be de-identified and randomized amongst participating urologists . By the retrospective nature of this study, cases may be several years post-RP. It is not expected that that participation in this study will have any impact on actual clinical management of patients.
Participants will be asked to complete two web-based electronic Case Report Questionnaires (eCRQ):
- Pre-Decipher: will collect information on their recommended treatment decision and their decision confidence based on the de-identified clinical and pathological information provided for each patient case.
- Post-Decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the Decipher test results.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Practicing urologic surgeons
Urologists will be excluded from participating in the study if:
All participants will be asked to complete a questionnaire based on a random selection of retroactively selected cases.
Other: Decipher Questionnaire
Each participant will complete the pre and post-Decipher eCRQs for a minimum of 5 cases, and a maximum of 25 cases.
- Change in treatment recommendation [ Time Frame: 1.5 years ]
Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation. Specifically this will be defined as (pre- to post-):
RT to ADT RT to ADT & RT RT to Observation ADT to RT ADT to ADT & RT ADT to Observation ADT & RT to RT ADT & RT to ADT ADT & RT to Observation Observation to RT Observation to ADT Observation to RT & ADT
- Specific change in treatment recommendation [ Time Frame: 1.5 years ]1. Change in treatment recommendation from pre- to post-Decipher report defined as any of the following: Observation to Any treatment Any treatment to Observation
- Changes in intensity of treatment [ Time Frame: 1.5 years ]
2. Change in treatment recommendation from pre- to post-Decipher report involving an increase or decrease in intensity defined as:
• Increasing intensity: RT to ADT RT to ADT & RT ADT to ADT & RT Observation to any treatment
• Decreasing intensity: Any treatment to observation ADT & RT to ADT ADT & RT to RT ADT to RT
- Change in treatment recommendation compared to baseline [ Time Frame: 1.5 years ]Changes in treatment recommendation (as described in the Primary Endpoint, and in Secondary Endpoints 1 and 2) from original, actual, treatment recommendation and post-Decipher recommendation.
- Confidence in treatment recommendation [ Time Frame: 1.5 years ]Changes in urologists expressed level of confidence in the treatment recommendation
- Changes in the decision conflict scale [ Time Frame: 1.5 years ]
- Utility of Decipher [ Time Frame: 1.5 years ]Urologist's perception regarding the utility of the Decipher test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034825
|United States, California|
|Cedar Associates LLC|
|Menlo Park, California, United States, 94025|
|United States, Florida|
|Celebration, Florida, United States, 34747|
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Badani K Ketan, MD||Columbia University|
|Study Director:||Christine d Buerki, PhD||GenomeDx Biosciences Inc.|
|Principal Investigator:||Vipul Patel, MD||AdventHealth|