CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Decipher Questionnaireother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02034812
NCT02034812N/ACompleted

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?

GenomeDx Biosciences Corp·observational·Posted Jan 14, 2014·Updated Feb 29, 2016

In Brief

An observational study evaluating Decipher Questionnaire for Prostate Cancer. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 14, 2014
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.5 years ago

Interventions

Decipher Questionnaireother

Pathological data from 12 de-identified patient cases will be reviewed by at least 25 Radiation Oncologists before and after exposure to the Decipher test results. Given the number of patient cases, reviewed by each participant, this allows for assessment of decision making based on 300 patient case reviews at each time point, immediately following RP and at the time of PSA rise.