NCT02700464

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Nucleix Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DEVICE	Bladder EpiCheck Urine Test	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
PROCEDURE	Cystoscopy and pathology	Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-04-01
• Completion: 2020-07-01
• First posted: 2016-03-07
• Last updated: 2021-05-04

Locations

11 sites across 2 countries: United States, Canada