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

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ClinicalTrials.gov Identifier: NCT02020876
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

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

Condition or disease Intervention/treatment
Prostate Cancer Other: DECIPHER Questionnaire

Detailed Description:
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)

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: GenomeDx Decipher Test for Metastatic Disease in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Physician Decision Making?
Study Start Date : August 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Practicing urologic surgeons
Performing at least 60 radical prostate surgeries annually
Other: 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.




Primary Outcome Measures :
  1. Change in treatment recommendation [ Time Frame: 1.5 years ]

    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.



Secondary Outcome Measures :
  1. Urologist's perception regarding the utility of the Decipher [ Time Frame: 1.5 years ]
    • Changes in Urologists expressed level of confidence in the treatment recommendation as measured by the response to item 4a in the eCRF survey.
    • Urologist's perception regarding the utility of the Decipher test as measured by the responses to question 4b and 38b and 38c in the eCRF survey.
    • Agreement in treatment recommendation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

Criteria (Participant enrollment)

Inclusion Criteria Study participants:

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

Exclusion Criteria Study Participants:

(1) Did not meet the inclusion criteria

Criteria (Case selection)

Inclusion Criteria Case File:

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 Case File:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020876


Locations
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United States, California
GenomeDx Bioscience Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
GenomeDx Biosciences Corp
Investigators
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Principal Investigator: Elai Davicioni, pHd GenomeDx Biosciences Inc.
Principal Investigator: Badani Ketan, MD Department of Urology, Columbia University, New York, NY USA
Publications of Results:
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Responsible Party: GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier: NCT02020876    
Other Study ID Numbers: CU001
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases