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

NCT02034812 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2016-02-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Decipher Questionnaire

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.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER
  • GenomeDx Biosciences Corp

    lead INDUSTRY

Principal Investigators

  • Paul L. Nguyen, MD · Dana-Farber Cancer Institute

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034812 on ClinicalTrials.gov