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

NCT06126796 | Completed

• 3 other identifiers: MDT-CxB-0123-008567NCI-2023-09278
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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

Non-muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Preference for CxBladder Monitor compared to cystoscopy

  Patient preference will be assessed based on the Preference Questionnaire (PQ) after completion of the study cross-over period (after both methods of testing have been experienced).

  Up to 6 months

Secondary Outcomes (5)

• Patient satisfaction

  Up to 6 months

• Change in symptoms and function - EORTC NMIBC-24

  Up to 6 months

• Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)

  Up to 6 months

• Financial costs

  Up to 6 months

• Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)

  Up to 6 months

Study Arms (2)

Arm A: CxBladder followed by cystoscopy

Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter

Diagnostic Test: CxBladder Monitor; Diagnostic Test: Cystoscopy

Arm B: cystoscopy followed by CxBladder

Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.

Diagnostic Test: CxBladder Monitor; Diagnostic Test: Cystoscopy

Interventions

CxBladder Monitor DIAGNOSTIC_TEST

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.

Also known as: CxBladder, CxbM

Arm A: CxBladder followed by cystoscopy; Arm B: cystoscopy followed by CxBladder

Cystoscopy DIAGNOSTIC_TEST

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.

Arm A: CxBladder followed by cystoscopy; Arm B: cystoscopy followed by CxBladder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female adult patients who are undergoing cystoscopic surveillance for NMIBC after at least 9 months of recurrence-free survival.

You may qualify if:

• Male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (NMIBC) who have at least 6 months of disease-free survival from last recurrence.
• Able to provide urine for testing and comply with study protocol.
• Have an email address and be willing to complete surveys online.

You may not qualify if:

• History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma)
• Patients with predominant (\>50%) variant histology
• Patients with a history of upper tract and/or urethral cancer
• Women who are pregnant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Mark D. Tyson, M.D., M.P.H.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: November 16, 2023
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)