RecruitingNCT05080998

Longitudinal Bladder Cancer Study for Tumour Recurrence

An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients

Sponsor

Pacific Edge Limited

Enrollment

450 participants

Start Date

Jun 8, 2022

Study Type

OBSERVATIONAL

Conditions

Urothelial Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking urine biomarkers over time in people with a history of bladder cancer (non-muscle-invasive) to see if a test called Cxbladder Monitor can detect tumor recurrence more accurately. **You may be eligible if...** - You are 18 or older with a prior confirmed diagnosis of non-muscle-invasive bladder cancer within the last 3 years - You are currently being monitored for recurrence - You are able to provide a voided urine sample (not via catheter) - You agree to 4 study visits with urine collection at each **You may NOT be eligible if...** - You have had your entire bladder removed or have a bladder substitute - You have had muscle-invasive bladder cancer (stage T2 or higher) - You are pregnant - You recently had a urinary procedure (catheterization, cystoscopy) within 14 days or an active urinary tract infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCxBladder 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

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NCT05080998

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