An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients

What this Trial Is About

Researchers are evaluating the CxBladder Monitor and Monitor+ urinary biomarker tests to detect recurrence of urothelial carcinoma (UC) in patients who have previously been diagnosed with this bladder cancer. Frequent cystoscopies are the current standard for surveillance but are invasive, costly, and time-consuming. This observational study aims to validate how well these urine tests can identify cancer recurrence compared to cystoscopy and pathology results over multiple visits. Participants include low-, intermediate-, and high-risk patients undergoing routine surveillance for UC recurrence. During up to four consecutive surveillance visits, patients will provide voided urine samples (not catheterized) for CxBladder testing and central urine cytology. Tissue samples from the original tumor and any recurrences within 12 weeks will be collected for molecular analysis. The study does not provide test results to patients or doctors and follows strict procedures for sample and data collection. Throughout the study, participants will attend four visits for urine sample collection and cystoscopy as part of their usual care. Researchers will measure the tests' sensitivity, specificity, predictive values, and negative rates compared to tumor findings confirmed by pathology. The study includes safety and quality oversight to ensure proper sample handling and adherence to guidelines. Participation lasts up to 12 months, during which multiple urine samples and tissue specimens are collected for research purposes.

Longitudinal Bladder Cancer Study for Tumour Recurrence