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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bladder EpiCheck Urine Test
Cystoscopy and pathology
Sponsored by
Nucleix Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Urology Center of Colorado
  • Chesapeake Urology Research Associates
  • Michigan Institute of Urology, P.C.
  • Metro Urology
  • Urological Surgeons of Long Island
  • Duke University Health System
  • Cleveland Clinic
  • Vanderbilt University Medical Center
  • Urology San Antonio
  • University Of Washington
  • UHN, Princess Margret Cancer center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bladder EpiCheck Urine Test

Gold Standard

Arm Description

Bladder EpiCheck Urine Test

Cystoscopy and pathology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 24, 2016
Last Updated
May 3, 2021
Sponsor
Nucleix Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02700464
Brief Title
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
Official Title
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nucleix Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
680 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bladder EpiCheck Urine Test
Arm Type
Experimental
Arm Description
Bladder EpiCheck Urine Test
Arm Title
Gold Standard
Arm Type
Active Comparator
Arm Description
Cystoscopy and pathology
Intervention Type
Device
Intervention Name(s)
Bladder EpiCheck Urine Test
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Cystoscopy and pathology
Intervention Description
Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy
Primary Outcome Measure Information:
Title
Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
Time Frame
Day 1
Title
Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmulik Adler, MSc
Organizational Affiliation
Nucleix Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Michigan Institute of Urology, P.C.
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Metro Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6158
Country
United States
Facility Name
UHN, Princess Margret Cancer center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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