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NCT03988309 · ClinicalTrials.gov registry record · NA
STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA
A NA study of Urothelial Carcinoma and Hematuria, sponsored by Pacific Edge Limited.
- Completed
- Registry status
- NA
- Development phase
- 554
- Enrollment target
- 12
- Study locations
NCT03988309: Completed NA study of Urothelial Carcinoma and Hematuria, sponsored by Pacific Edge Limited.
NCT03988309 is a NA study of Urothelial Carcinoma and Hematuria that has completed, run by Pacific Edge Limited. The registered enrollment target is 554 participants, above the 233-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (138% higher). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03988309, a NA study of Urothelial Carcinoma and Hematuria, has completed, sponsored by Pacific Edge Limited.
- COMPLETED
- Registry status
- NA
- Development phase
- 554 participants
- Enrollment target
- 12
- Study locations
Study Summary
To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.
Primary Outcome
To evaluate the increase in utility as defined by the reduction in cystoscopy procedure count when Cxbladder is used in the evaluation. The comparison will be made when comparing test and control arms on a per subject basis. The gold standard for determination of a confirmed clinical diagnosis is cystoscopy confirmed by pathology, plus imaging or any follow-up investigations relating to the visit.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Cxbladder
Study Locations (12)
Minnesota
- Allina Health Cancer Institute - Minneapolis
- University of Minnesota, Department of Urology - Minneapolis
Texas
- UT Southwestern Medical Center - Dallas
- UTHSA - Mays Cancer Center - San Antonio
California
- Institute of Urology, USC Norris Comprehensive Cancer Center - Los Angeles
Florida
- Avant Concierge Urology - Winter Garden
Illinois
- Accellacare - Chicago
Pennsylvania
- Division of urology, Penn State Milton S Hershey Medical Center - Hershey
South Carolina
- Carolina Urologic Research Center - Myrtle Beach
Tennessee
- Department of Urology,Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 554 participants |
| Start Date | 2019-09-11 |
| Est. Completion | 2024-07-24 |
| Phase | NA |
What the finished NCT03988309 record still lists
NCT03988309 is an interventional study that assigns participants to a tested intervention. The registered 554 participants enrollment target is mid-sized for trials with a published cap, above the 233-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (138% higher).
The record links to 2 conditions, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Cxbladder is the first listed.
NCT03988309 lists 12 locations in 10 states (Minnesota, Texas, California).
Frequently Asked Questions
What is clinical trial NCT03988309 about?
NCT03988309 is a clinical study titled "STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA". To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.
What is the current status of trial NCT03988309?
This trial is currently completed. It is a NA study. The enrollment target is 554 participants. The study started on 2019-09-11. Estimated completion is 2024-07-24.
What conditions does trial NCT03988309 study?
This clinical trial studies the following conditions: Urothelial Carcinoma, Hematuria.
What interventions are being tested in trial NCT03988309?
The interventions under investigation include: Cxbladder (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03988309?
This trial is sponsored by Pacific Edge Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03988309 being conducted?
This trial has 12 study locations across California, Florida, Illinois, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03988309's enrollment target sits among peer trials
554 11th of 85 higher than 75 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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