The Cxbladder Monitoring Study

A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)

The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy.

The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.

Inclusion Criteria:

• Confirmed positive diagnosis for primary or recurrent urinary tract UC over the past 2 years.
• Patient is undergoing investigative cystoscopies for the monitoring of recurrence of UC at intervals prescribed by a clinical practitioner
• Patient is 18 years of age or older.

Exclusion Criteria:

• Prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
• Patient has undergone total bladder cystectomy as treatment for bladder UC