An observational study in Non-muscle Invasive Bladder Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Mayo Clinic · Observational
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.
265 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 113 are open to participants now.
This study's enrollment of 107 is below the median of 206 across 46 observational studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Male or female adult patients who are undergoing cystoscopic surveillance for NMIBC after at least 9 months of recurrence-free survival.
Exclusion Criteria:
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 will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.
Diagnostic Test: CxBladder Monitor · Diagnostic Test: Cystoscopy
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
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.
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).
Time frame: Up to 6 months
Patient satisfaction
Patient satisfaction will be assessed based on the Satisfaction Questionnaire (SQ) after completion of each test at 3 and 6 months.
Time frame: Up to 6 months
Change in symptoms and function - EORTC NMIBC-24
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer (EORTC NMIBC-24) will be used to assess Health-related quality of life. The questionnaire consists of 24 items scored on a four-point Likert scale ranging from 1 (not at all) to 4 (very much), with the exception of the global health status items, which employ a seven-point scale ranging from 1 (very poor) to 7 (excellent). Higher scores are interpreted as more symptom burden, with exception of the sexual function and sexual enjoyment sections, where higher scores represent better functioning.
Time frame: Up to 6 months
Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
Health-related quality of life will be assessed based on the Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) at baseline, 3 months (within 1 week of test), and 6 months (within 1 week of test). The nine-item FCRI evaluates the presence and severity of intrusive thoughts associated with FCR. Each item is rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time"). A higher score indicates higher levels of FCR.
Time frame: Up to 6 months
Financial costs
Assessed by patient responses to questions about missed work and time missed from usual activities.
Time frame: Up to 6 months
Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)
Error rate for CxBladder is defined as the proportion of patients who have a negative CxBladder at 3 months but have a recurrence identified on cystoscopy at 6 months for patients in arm A. The error rate for cystoscopy is defined as the proportion of patients who have a negative cystoscopy at 3 months but have a positive CxBladder at 6 months that is subsequently confirmed by cystoscopy for patients in arm B.
Time frame: Up to 6 months
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Non-Muscle Invasive Bladder Neoplasms→
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