At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Low-grade intermediate-risk non-muscle-invasive bladder cancer defined by specific pathology patterns
- ✓Multifocal low-grade non-invasive urothelial carcinoma of any size
- ✓Solitary low-grade non-invasive urothelial carcinoma >3 cm
- ✕History of total cystectomy
- ✕History of urinary diversion
- ✕History of muscle-invasive bladder tumor
- ✕Pregnancy or lactation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
In Brief
A Phase 2 clinical trial evaluating Cystoscopy, Bladder EpiCheck urine test, and 1 other intervention for Non-muscle-invasive Bladder Cancer. Currently recruiting, targeting 240 participants across 9 sites.
Detailed Summary
The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.
Study Details
Timeline
Interventions
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
The Bladder EpiCheck is a laboratory-developed test for early-stage non-muscle invasive bladder cancer. The Bladder EpiCheck test is a DNA methylation test that is run on DNA extracted from cell pellet from centrifuged urine according to Standardized Operating Procedures. The test has internal controls and a dedicated software to ensure required quality assurance processes and prompt reporting of results.
A 4.5 ml sample of voided urine is added to Xpert® Urine Transport Reagent, mixed, and then 4ml of treated urine are transferred to the Sample Chamber of the cartridge. In the cartridge, cells in the urine sample are captured on a filter and lysed by sonication. The released nucleic acid is eluted, mixed with dry RT-PCR reagents, and the solution is transferred to the reaction tube for RT-PCR and detection.