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NCT05889195 · ClinicalTrials.gov registry record
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
A clinical trial of Urothelial Carcinoma, sponsored by Pacific Edge Limited.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 4
- Study locations
NCT05889195: Recruiting study of Urothelial Carcinoma, sponsored by Pacific Edge Limited.
NCT05889195 is a study of Urothelial Carcinoma that is actively recruiting participants, run by Pacific Edge Limited. The registered enrollment target is 1,000 participants, above the 227-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (341% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05889195, a study of Urothelial Carcinoma, is actively recruiting participants, sponsored by Pacific Edge Limited.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 4
- Study locations
Study Summary
It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.
Primary Outcome
Cxbladder Triage-Plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Cxbladder urine test
Study Locations (4)
California
- Tri Valley Urology Medical Group - Murrieta
New York
- AccuMed Research Associates - Garden City
North Carolina
- Durham VA Health Care System - Durham
Texas
- The Urology Place - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-11-02 |
| Est. Completion | 2026-03-31 |
What NCT05889195 shows while recruiting
NCT05889195 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 227-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (341% higher).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Cxbladder urine test is the first listed.
NCT05889195 reports a single indexed study location in California, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05889195 about?
NCT05889195 is a clinical study titled "Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria". It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that...
What is the current status of trial NCT05889195?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2023-11-02. Estimated completion is 2026-03-31.
What conditions does trial NCT05889195 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT05889195?
The interventions under investigation include: Cxbladder urine test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05889195?
This trial is sponsored by Pacific Edge Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05889195 being conducted?
This trial has 4 study locations across California, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05889195's enrollment target sits among peer trials
1,000 4th of 85 higher than 81 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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