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Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)

NCT06126796 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 107

Last updated 2026-01-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.

Conditions

Interventions

DIAGNOSTIC_TEST

CxBladder Monitor

CxBladder Monitor (CxbM) is an FDA-approved genomic biomarker test specifically designed for patients undergoing surveillance for NMIBC. The non-invasive urine test quantifies 5 measured biomarker genes (MDK, HOXA13, CDC2 (CDK1), IGFBP5, CXCR2) and incorporates this information into an algorithm to detect the presence or absence of bladder cancer.

DIAGNOSTIC_TEST

Cystoscopy

Cystoscopy is the most common way surveillance has been performed for NMIBC. Cystoscopy is a procedure that allows your doctor to examine the lining of your bladder and the tube that carries urine out of your body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into your bladder.

Sponsors & Collaborators

Principal Investigators

  • Mark D. Tyson, M.D., M.P.H. · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2025-09-08
Completion
2025-09-08

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT06126796 on ClinicalTrials.gov