Clinical trial NCT02700464: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 680
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)
timeFrame: Day 1
measure: Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology, P.C.
state: Michigan
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
city: Garden City
country: United States
facility: Urological Surgeons of Long Island
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Seattle
country: United States
facility: University Of Washington
state: Washington
city: Toronto
country: Canada
facility: UHN, Princess Margret Cancer center
state: Ontario
Study officials:
affiliation: Nucleix Ltd.
name: Shmulik Adler, MSc
role: STUDY_DIRECTOR
References: