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STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA
NCT03988309 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03988309
The ClinicalTrials.gov registry entry for NCT03988309 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 554 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacific Edge Limited, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03988309 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Minnesota, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03988309?
The interventions under investigation include: Cxbladder (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03988309?
This trial is sponsored by Pacific Edge Limited, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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