An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characterisitc of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.
• Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.
• Subjects must agree to 4 successive study visits, including urine sample collection at each visit.
• Physically able to provide a voided urine sample (a sample from catheterization is not eligible).
• Able to give written informed consent
• Able and willing to comply with study requirements
• Aged 18 years or older