MedTrace Logo

Longitudinal Bladder Cancer Study for Tumour Recurrence

NCT05080998 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2025-11-10

No results posted yet for this 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

  • Urothelial Bladder Cancer

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.

Sponsors & Collaborators

  • Pacific Edge Limited

    lead INDUSTRY

Principal Investigators

  • Tony Lough · Pacific Edge Pty Ltd

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2026-05-30
Completion
2026-08-31

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05080998 on ClinicalTrials.gov