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

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Device: Bladder EpiCheck Urine Test; Procedure: Cystoscopy and pathology

• Registration Number: NCT02700464
• Lead Sponsor: Nucleix Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Study Start: 2016-09
• Primary Completion: 2020-04
• Status Verified: 2020-07
• Study Completion: 2020-07
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

• Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
• Has had all urothelial cell carcinoma tumor resected within the past 12 months
• Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
• Able to provide legally effective informed consent
• Able to produce 45mL of urine

Exclusion Criteria

• Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bladder EpiCheck Urine Test	Bladder EpiCheck Urine Test	Bladder EpiCheck Urine Test
Gold Standard	Cystoscopy and pathology	Cystoscopy and pathology

Primary Outcome Measures

Name	Time	Method
Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)	Day 1
Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)	Day 1

Trial Locations

Locations (11)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

The Urology Center of Colorado; 🇺🇸 Denver, Colorado, United States

Urological Surgeons of Long Island; 🇺🇸 Garden City, New York, United States

UHN, Princess Margret Cancer center; 🇨🇦 Toronto, Ontario, Canada

Duke University Health System; 🇺🇸 Durham, North Carolina, United States

University Of Washington; 🇺🇸 Seattle, Washington, United States

Chesapeake Urology Research Associates; 🇺🇸 Baltimore, Maryland, United States

Michigan Institute of Urology, P.C.; 🇺🇸 Troy, Michigan, United States

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States

Metro Urology; 🇺🇸 Woodbury, Minnesota, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States