A Randomized Cross-Over Study to Evaluate Patient Preference and Satisfaction With Urine-based Molecular Testing Versus Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
Overview
- Phase
- Not Applicable
- Intervention
- CxBladder Monitor
- Conditions
- Non-muscle Invasive Bladder Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Preference for CxBladder Monitor compared to cystoscopy
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Mark D. Tyson II, M.D., M.P.H.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Arm A: CxBladder followed by cystoscopy
Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter
Intervention: CxBladder Monitor
Arm A: CxBladder followed by cystoscopy
Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter
Intervention: Cystoscopy
Arm B: cystoscopy followed by CxBladder
Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.
Intervention: CxBladder Monitor
Arm B: cystoscopy followed by CxBladder
Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.
Intervention: Cystoscopy
Outcomes
Primary Outcomes
Preference for CxBladder Monitor compared to cystoscopy
Time Frame: Up to 6 months
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).
Secondary Outcomes
- Patient satisfaction(Up to 6 months)
- Change in symptoms and function - EORTC NMIBC-24(Up to 6 months)
- Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)(Up to 6 months)
- Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)(Up to 6 months)
- Financial costs(Up to 6 months)