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ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery
This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.
The clinical utility of Decipher will be evaluated at two time-points: 1. Post RP - within 6 months after surgery 2. 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): 1. 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. 2. Post-Decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the Decipher test results.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Cedar Associates LLC
Menlo Park, California, United States
Florida Hospital
Celebration, Florida, United States
Columbia University
New York, New York, United States
Start Date
January 1, 2013
Primary Completion Date
January 1, 2015
Completion Date
January 1, 2015
Last Updated
February 29, 2016
50
ESTIMATED participants
Decipher Questionnaire
OTHER
Lead Sponsor
GenomeDx Biosciences Corp
Collaborators
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494