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

NCT02020876 | Completed

• 1 other identifier: CU001
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in treatment recommendation

  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.

  1.5 years

Secondary Outcomes (1)

• Urologist's perception regarding the utility of the Decipher

  1.5 years

Study Arms (1)

Practicing urologic surgeons

Performing at least 60 radical prostate surgeries annually

Other: DECIPHER Questionnaire

Interventions

DECIPHER Questionnaire OTHER

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.

Practicing urologic surgeons

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. The study participants are the urologists who review the selected case files.

You may qualify if:

• Practicing board-certified urologic surgeons
• Performing at least 40 radical prostate surgeries annually

You may not qualify if:

• Criteria (Case selection)
• Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as:
• Pathological Gleason score \>= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery
• Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)

Sponsors & Collaborators

• GenomeDx Biosciences Corp: lead

Study Sites (1)

GenomeDx Bioscience Inc.

San Diego, California, 92121, United States

Location

Related Publications (1)

• Badani K, Thompson DJ, Buerki C, Davicioni E, Garrison J, Ghadessi M, Mitra AP, Wood PJ, Hornberger J. Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. Oncotarget. 2013 Apr;4(4):600-9. doi: 10.18632/oncotarget.918.

  PMID: 23592338 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Elai Davicioni, pHd

  GenomeDx Biosciences Inc.

  PRINCIPAL INVESTIGATOR

• Badani Ketan, MD

  Department of Urology, Columbia University, New York, NY USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 25, 2013
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

US (1)