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Arm A: CxBladder followed by cystoscopy for Bladder Cancer
N/A
Recruiting
Led By Mark D. Tyson, M.D., M.P.H.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study 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.
Eligible Conditions
- Bladder Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Preference for CxBladder Monitor compared to cystoscopy
Secondary outcome measures
Change in symptoms and function - EORTC NMIBC-24
Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)
Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: cystoscopy followed by CxBladderExperimental Treatment2 Interventions
Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.
Group II: Arm A: CxBladder followed by cystoscopyExperimental Treatment2 Interventions
Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cystoscopy
2016
Completed Phase 4
~810
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,976 Total Patients Enrolled
Mark D. Tyson, M.D., M.P.H.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
704 Total Patients Enrolled
Frequently Asked Questions
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