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NCT05080998 · ClinicalTrials.gov registry record
Longitudinal Bladder Cancer Study for Tumour Recurrence
A clinical trial of Urothelial Bladder Cancer, sponsored by Pacific Edge Limited.
- Recruiting
- Registry status
- 450
- Enrollment target
- 7
- Study locations
NCT05080998: Recruiting study of Urothelial Bladder Cancer, sponsored by Pacific Edge Limited.
NCT05080998 is a study of Urothelial Bladder Cancer that is actively recruiting participants, run by Pacific Edge Limited. The registered enrollment target is 450 participants. The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05080998, a study of Urothelial Bladder Cancer, is actively recruiting participants, sponsored by Pacific Edge Limited.
- RECRUITING
- Registry status
- 450 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
To clinically validate the performance characteristics - sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and test-negative rate of Monitor and Monitor+ for the detection of recurrent UC in subjects with a recent history of urinary tract UC who are being treated according to standard of care and are concurrently undergoing routine investigative cystoscopy.
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 |
What NCT05080998 shows while recruiting
NCT05080998 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT05080998 lists 7 locations in 6 states (Florida, South Carolina, Texas).
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.
What interventions are being tested in trial NCT05080998?
The interventions under investigation include: CxBladder Monitor/Monitor+ (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05080998?
This trial is sponsored by Pacific Edge Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
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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