French Clinic conducts Evaluation Study of the Xpert® Bladder Cancer Monitor Test

Beau Soleil Clinic (Clinique Beau Soleil) is commencing recruitment for the clinical trial of the Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.

The conditions are Non-Invasive Bladder Urothelial Carcinoma, Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade, Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade.

A new clinical trial is recruiting patients in the following locations: Clinique Beau Soleil, Montpellier, Hérault, France, 34070.

The trial officially began on the May 22, 2019 and is planned to complete on December 2021.

Non-muscle invasive bladder tumor is a condition that can recur with a risk of progression to an infiltrating tumor of the muscle. Regular follow-up is therefore essential to detect any recurrence or progression of the disease as early as possible.

Currently, the monitoring of this type of tumor is done by cystoscopy (examination that allows visualization of the bladder wall) associated with urinary cytology (analysis of urine to detect an abnormality). These examinations have their limits, they may not detect certain types of tumors or may be painful.

To reduce the number of cystoscopies and replace urinary cytology, several urinary markers have been developed in recent years. This is the case of the Xpert® Bladder Cancer Monitor test, which is a non-invasive, in vitro diagnostic urine test dedicated to the monitoring of patients with bladder cancer.

The purpose of this study is to evaluate the diagnostic performance of the Xpert® Bladder Cancer Monitor test for the detection of bladder tumor recurrence, compared to reference tests.

Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test is the primary outcome measure.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04647981