Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05080998

Longitudinal Bladder Cancer Study for Tumour Recurrence

Sponsor: Pacific Edge Limited

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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