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The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma

Bladder Cancer Clinical Trial

Official title:
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study

Clinical Trial Summary

Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.

Clinical Trial Description

The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02700464
Study type Interventional
Source Nucleix Ltd.
Contact
Status Completed
Phase N/A
Start date September 2016
Completion date July 2020
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