Validation of Cxbladder® Triage and Monitor as an Adjunct to Urothelial Carcinoma Diagnosis and Surveillance in a Single Centre.

Abstract

Objective: Bladder cancer is the 10^th most common cancer worldwide. The investigation and surveillance commonly involve a combination of upper tract imaging along with visual assessment of the bladder via cystoscopy. This study determined the validity of using Cxbladder^® Triage (CxbT) and Cxbladder^® Monitor (CxbM) as a suitable adjunct in ruling out urothelial carcinoma (UC) when investigating haematuria or monitoring for recurrence.

Materials and methods: A single centre prospective study where the patients have been referred for investigation of UC or those on routine surveillance of known UC. All patients were counselled with consent obtained prior to midstream urine collection pre-cystoscopy in line with local protocol for urine-analysis to screen for infection with the residual specimen collected for the CxbT or CxbM test. De-identified patient demographic data along with smoking status, risk of environmental exposures, family history, type of hematuria or last date of last recurrence were collected, and the planned cystoscopy would then proceed. The data pertaining to exposure to smoking and type of haematuria are the symptoms and risk factors that are taken into account with CxbT or CxbM to calculate a score, which can then be correlated with the outcome at the end with cystoscopic and imaging investigations.

Results: A combined 236 patients were recruited (CxbT = 134, CxbM = 102) with results showing excellent negative predictive value of 96.43% and 95.16%, respectively. A key result showed that CxbT in combination with upper tract imaging done as routine was able to rule out UC completely in low-risk patients.

Conclusion: We have validated the use of Cxbladder as an adjunct in the investigation and surveillance of UC. It is a non-invasive, accurate and reproducible test that can aid in ruling out UC, specifically for low-risk patients.