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

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ClinicalTrials.gov Identifier: NCT02700464
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : August 21, 2017
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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


Contacts
Contact: Shmulik Adler, MSc 011-972-8-9161616 ext 117 shmulik@nucleix.com

Locations
United States, Maryland
Chesapeake Urology Research Associates Recruiting
Baltimore, Maryland, United States, 21237
Contact: Renee Hammond    443-471-5749    rhammond@cua.md   
Principal Investigator: Anup Shah, MD         
United States, Minnesota
Metro Urology Not yet recruiting
Woodbury, Minnesota, United States, 55125
Contact: Diane Kachel    612-819-0533    DKachel@mnurology.com   
Principal Investigator: Peter Sershon, MD         
United States, New York
Urological Surgeons of Long Island Recruiting
Garden City, New York, United States, 11530
Contact: Diane Gerrity    516-742-3200 ext 302    dgerrity@prohealthcare.com   
Principal Investigator: Jeffrey Lumerman, MD         
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Denise Lech    919-681-7348    denise.lech@duke.edu   
Principal Investigator: Brant Inman, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joanna Homann    216-444-0124    HOMANNJ@ccf.org   
Principal Investigator: Ryan Berglund, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Pam Steele, RN    615-343-2120    pamela.steele@Vanderbilt.Edu   
Principal Investigator: Moses Kelvin, MD         
United States, Texas
Urology San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Jennifer Cruz    210-617-4116    Jennifer.Cruz@urologysa.com   
Principal Investigator: Daniel Saltzstein, MD         
United States, Washington
University Of Washington Recruiting
Seattle, Washington, United States, 98195-6158
Contact: Alexandria Lahdya    949-294-9084    azlahdya@uw.edu   
Principal Investigator: Jonathan Wright, MD         
Canada, Ontario
UHN, Princess Margret Cancer center Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Parisa Sairafi    416-946-4501 ext 5514    Parisa.Sairafi@uhn.ca   
Principal Investigator: Neil Fleshner, MD         
Sponsors and Collaborators
Nucleix Ltd.
Investigators
Study Director: Shmulik Adler, MSc Nucleix Ltd.

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: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases