Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
NCT ID: NCT06126796
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
107 participants
OBSERVATIONAL
2023-11-16
2025-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm A: CxBladder followed by cystoscopy
Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter
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.
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.
Arm B: cystoscopy followed by CxBladder
Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide urine for testing and comply with study protocol.
* Have an email address and be willing to complete surveys online.
Exclusion Criteria
* Patients with predominant (\>50%) variant histology
* Patients with a history of upper tract and/or urethral cancer
* Women who are pregnant
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mark D. Tyson II, M.D., M.P.H.
Principal Investigator
Principal Investigators
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Mark D. Tyson, M.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-008567
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2023-09278
Identifier Type: REGISTRY
Identifier Source: secondary_id
MDT-CxB-01
Identifier Type: -
Identifier Source: org_study_id
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