This study tests patients' preference of using a urine based molecular test versus cystoscopy for patients undergoing surveillance of non-muscle invasive bladder cancer. 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. Cystoscopy can be painful, anxiety-provoking, and inconvenient for patients which negatively impacts compliance. Urine based molecular testing may improve patient satisfaction among patients undergoing surveillance for non-muscle invasive bladder cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06126796.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate patient preference for CxBladder Monitor compared with cystoscopy.
SECONDARY OBJECTIVE:
I. To evaluate patient-assessed satisfaction with CxBladder Monitor compared with cystoscopy.
II. To evaluate patients’ choice of CxBladder Monitor for the surveillance continuation period.
III. To evaluate health related quality of life (HRQoL) with CxBladder compared to cystoscopy.
IV. To evaluate fear of cancer recurrence with CxBladder compared to cystoscopy.
V. To evaluate financial costs, including time missed from work and usual activities.
VI. To compare the error rate of CxBladder and cystoscopy in identifying recurrent NMIBC.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo testing with CxBladder urine based testing 3 months after randomization followed by cystoscopy 3 months thereafter. Patients then select between continuing surveillance with CxBladder alternated with cystoscopy or cystoscopy only with the frequency recommended by the treating physician.
ARM II: Patients undergo cystoscopy 3 months after randomization followed by testing with CxBladder urine based testing 3 months thereafter. Patients then select between continuing surveillance with CxBladder alternated with cystoscopy or cystoscopy only with the frequency recommended by the treating physician.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationMayo Clinic in Arizona
Principal InvestigatorMark D. Tyson
