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Longitudinal Bladder Cancer Study for Tumour Recurrence
Sponsor: Pacific Edge Limited
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.
Official title: An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
450
Start Date
2022-06-08
Completion Date
2026-08-31
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
CxBladder Monitor/Monitor+
CxBladder Monitor/Monitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.
Locations (7)
Miami VA Healthcare System
Miami, Florida, United States
James A. Haley Veteran's Hospital
Tampa, Florida, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
White River Junction Veterans Affair Medical Center
White River Junction, Vermont, United States
University of Washington School of Medicine
Seattle, Washington, United States
Monash Health - Moorabbin Hospital
Clayton, Victoria, Australia