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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Bladder EpiCheck Urine Test; Procedure: Cystoscopy and pathology

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 Type: Interventional
• Enrollment (Actual): 680
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • UHN, Princess Margret Cancer center
• United States
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Chesapeake Urology Research Associates
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology, P.C.
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Metro Urology
  • New York
    • Garden City, New York, United States, 11530
      • Urological Surgeons of Long Island
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio
  • Washington
    • Seattle, Washington, United States, 98195-6158
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bladder EpiCheck Urine Test	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
Active Comparator: Gold Standard; Cystoscopy and pathology	Procedure: Cystoscopy and pathology; Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nucleix Ltd.
• Investigators: Study Director: Shmulik Adler, MSc, Nucleix Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: UC-EpiCheck-FDA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No