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

NCT ID: NCT02020876

Last Updated: 2013-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

Detailed Description

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The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Practicing urologic surgeons

Performing at least 60 radical prostate surgeries annually

DECIPHER Questionnaire

Intervention Type 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.

Interventions

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DECIPHER Questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Practicing board-certified urologic surgeons
2. Performing at least 40 radical prostate surgeries annually


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

Exclusion Criteria

Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GenomeDx Biosciences Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elai Davicioni, pHd

Role: PRINCIPAL_INVESTIGATOR

GenomeDx Biosciences Inc.

Badani Ketan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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GenomeDx Bioscience Inc.

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23592338 (View on PubMed)

Other Identifiers

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CU001

Identifier Type: -

Identifier Source: org_study_id