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NCT03031418 · ClinicalTrials.gov registry record
Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
A clinical trial of Cancer Of Prostate, sponsored by Exosome Diagnostics.
- Completed
- Registry status
- 532
- Enrollment target
- 18
- Study locations
NCT03031418: Completed study of Cancer Of Prostate, sponsored by Exosome Diagnostics.
NCT03031418 is a study of Cancer Of Prostate that has completed, run by Exosome Diagnostics. The registered enrollment target is 532 participants, below the 1,863-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (71% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03031418, a study of Cancer Of Prostate, has completed, sponsored by Exosome Diagnostics.
- COMPLETED
- Registry status
- 532 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).
Primary Outcome
Confirm performance of the ExoDx Prostate IntelliScore utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated prostate-specific antigen (2-10 ng/mL).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST ExoDx Prostate Intelliscore
Study Locations (18)
New York
- Manhattan Medical Research - New York
- NYU Urology Associates - New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University Medical Center - New York
New Jersey
- Premier Urology Group - Edison
- Urologic Research and Consulting LLC - Englewood
- Delaware Valley Urology - Voorhees Township
Florida
- 21st Century Oncology - Fort Myers
- Mount Sinai Medical Center of Florida - Miami
Maryland
- Johns Hopkins University - Baltimore
- Walter Reed National Military Medical CPDR - Bethesda
Georgia
- Southeastern Urology Associates - Macon
Michigan
- Comprehensive Urology - Royal Oak
Montana
- Five Valley Urology - Missoula
North Carolina
- Associated Urologists of North Carolina - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2018-09-01 |
What the finished NCT03031418 record still lists
NCT03031418 is an observational study that tracks outcomes without assigning an intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap, below the 1,863-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Cancer Of Prostate appearing as the primary indexed condition, and to 1 intervention - of which ExoDx Prostate Intelliscore is the first listed.
NCT03031418 lists 18 locations in 11 states (New York, New Jersey, Florida).
Frequently Asked Questions
What is clinical trial NCT03031418 about?
NCT03031418 is a clinical study titled "Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)". The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already s...
What is the current status of trial NCT03031418?
This trial is currently completed. The enrollment target is 532 participants. The study started on 2016-09-01. Estimated completion is 2018-09-01.
What conditions does trial NCT03031418 study?
This clinical trial studies the following conditions: Cancer Of Prostate.
What interventions are being tested in trial NCT03031418?
The interventions under investigation include: ExoDx Prostate Intelliscore (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03031418?
This trial is sponsored by Exosome Diagnostics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03031418 being conducted?
This trial has 18 study locations across Florida, Georgia, Maryland, Michigan, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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