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Longitudinal Bladder Cancer Study for Tumour Recurrence
NCT05080998 · View on ClinicalTrials.gov ↗
Study Summary
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST CxBladder Monitor/Monitor+
Study Locations (7)
Florida
- Miami VA Healthcare System — Miami
- James A. Haley Veteran's Hospital — Tampa
South Carolina
- Ralph H. Johnson VA Health Care System — Charleston
Texas
- UT Southwestern Medical Center — Dallas
Vermont
- White River Junction Veterans Affair Medical Center — White River Junction
Washington
- University of Washington School of Medicine — Seattle
Victoria
- Monash Health - Moorabbin Hospital — Clayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-06-08 |
| Est. Completion | 2026-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05080998
The ClinicalTrials.gov registry entry for NCT05080998 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 450 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 1 condition, with Urothelial Bladder Cancer appearing as the primary indexed condition, and to 1 intervention — of which CxBladder Monitor/Monitor+ 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: NCT05080998 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Florida, South Carolina, Texas. 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 NCT05080998 about?
NCT05080998 is a clinical study titled "Longitudinal Bladder Cancer Study for Tumour Recurrence". Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm,...
What is the current status of trial NCT05080998?
This trial is currently recruiting. The enrollment target is 450 participants. The study started on 2022-06-08. Estimated completion is 2026-08-31.
What conditions does trial NCT05080998 study?
This clinical trial studies the following conditions: Urothelial Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05080998?
The interventions under investigation include: CxBladder Monitor/Monitor+ (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05080998?
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 NCT05080998 being conducted?
This trial has 7 study locations across Florida, South Carolina, Texas, Vermont, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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