Trials / Completed
CompletedNCT02702856
Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (actual)
- Sponsor
- Exosome Diagnostics, Inc. · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
Validate a non-DRE exosome gene expression test, with an NPV \>/= 90% certainty, will exclude the presence of high gleason grade/ score (\>/=7) prostate cancer in a prostate needle biopsy.
Detailed description
The purpose of this multi-center clinical study is to determine the association of an Exosome Urine Test score with the presence of high Gleason grade / score (GS\>/=7) prostate cancer on a prostate needle biopsy and validate the assay's performance characteristics in men presenting to their urologist with or without a previous negative biopsy, and recommended for an initial or subsequent biopsy. The results of this study are to support the use of this assay as a laboratory developed test. A secondary objective is to develop an assay that accurately predicts the presence of any Gleason grade prostate cancer in men at risk for prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | ExoIntelliScore Prostate |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2015-04-01
- Completion
- 2015-06-01
- First posted
- 2016-03-09
- Last updated
- 2016-03-09
Source: ClinicalTrials.gov record NCT02702856. Inclusion in this directory is not an endorsement.