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NCT02700464 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT02700464
Other study ID # UC-EpiCheck-FDA-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date July 2020

Study information
Verified date July 2020
Source Nucleix Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 680
Est. completion date July 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada UHN, Princess Margret Cancer center Toronto Ontario
United States Chesapeake Urology Research Associates Baltimore Maryland
United States Cleveland Clinic Cleveland Ohio
United States The Urology Center of Colorado Denver Colorado
United States Duke University Health System Durham North Carolina
United States Urological Surgeons of Long Island Garden City New York
United States Vanderbilt University Medical Center Nashville Tennessee
United States Urology San Antonio San Antonio Texas
United States University Of Washington Seattle Washington
United States Michigan Institute of Urology, P.C. Troy Michigan
United States Metro Urology Woodbury Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Nucleix Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard) Day 1
Primary Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard) Day 1
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