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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.

Tracking Information
First Submitted Date  ICMJE February 24, 2016
First Posted Date  ICMJE March 7, 2016
Last Update Posted Date August 21, 2017
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02700464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
Official Title  ICMJE The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Bladder EpiCheck Urine Test
    Bladder EpiCheck Urine Test
    Intervention: Device: Bladder EpiCheck Urine Test
  • Active Comparator: Gold Standard
    Cystoscopy and pathology
    Intervention: Procedure: Cystoscopy and pathology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shmulik Adler, MSc 011-972-8-9161616 ext 117 shmulik@nucleix.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02700464
Other Study ID Numbers  ICMJE UC-EpiCheck-FDA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nucleix Ltd.
Study Sponsor  ICMJE Nucleix Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shmulik Adler, MSc Nucleix Ltd.
PRS Account Nucleix Ltd.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP