Clinical Trial: NCT02700464 - My Cancer Genome

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:

Completed

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02700464

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

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

Name	Type	Description	Interventions
Bladder EpiCheck Urine Test	Experimental	Bladder EpiCheck Urine Test
Gold Standard	Active Comparator	Cystoscopy 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:	Completed
Lead Sponsor:	Nucleix Ltd.

Last Updated

May 4, 2021

Clinical Trials /

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