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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700464
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: Bladder EpiCheck Urine Test Procedure: Cystoscopy and pathology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bladder EpiCheck Urine Test
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700464


Locations
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United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21237
United States, Minnesota
Metro Urology
Woodbury, Minnesota, United States, 55125
United States, New York
Urological Surgeons of Long Island
Garden City, New York, United States, 11530
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Urology San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
University Of Washington
Seattle, Washington, United States, 98195-6158
Canada, Ontario
UHN, Princess Margret Cancer center
Toronto, Ontario, Canada, M5G 1Z5
Sponsors and Collaborators
Nucleix Ltd.
Investigators
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Study Director: Shmulik Adler, MSc Nucleix Ltd.

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Responsible Party: Nucleix Ltd.
ClinicalTrials.gov Identifier: NCT02700464     History of Changes
Other Study ID Numbers: UC-EpiCheck-FDA-01
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases