Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
- Conditions
- Non-muscle Invasive Bladder Cancer
- Interventions
- Diagnostic Test: CxBladder MonitorDiagnostic Test: Cystoscopy
- Registration Number
- NCT06126796
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 107
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm A: CxBladder followed by cystoscopy CxBladder Monitor Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter Arm B: cystoscopy followed by CxBladder CxBladder Monitor Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter. Arm B: cystoscopy followed by CxBladder Cystoscopy Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter. Arm A: CxBladder followed by cystoscopy Cystoscopy Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter
- Primary Outcome Measures
Name Time Method Preference for CxBladder Monitor compared to cystoscopy 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 Outcome Measures
Name Time Method Patient satisfaction Up to 6 months Patient satisfaction will be assessed based on the Satisfaction Questionnaire (SQ) after completion of each test at 3 and 6 months.
Change in symptoms and function - EORTC NMIBC-24 Up to 6 months 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.
Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC) Up to 6 months 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.
Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) Up to 6 months 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.
Financial costs Up to 6 months Assessed by patient responses to questions about missed work and time missed from usual activities.
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States