Clinical Trials /

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

NCT02700464

Description:

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.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: UC-EpiCheck-FDA-01
  • NCT ID: NCT02700464

Conditions

  • Bladder Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Bladder EpiCheck Urine TestExperimentalBladder EpiCheck Urine Test
    Gold StandardActive ComparatorCystoscopy and pathology

      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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:22 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure: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
      Safety Issue:
      Description:

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Nucleix Ltd.

      Last Updated

      March 1, 2016