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

Nucleix

Status: Completed

Conditions: Bladder Cancer

Treatments: Procedure: Cystoscopy and pathology; Device: Bladder EpiCheck Urine Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT02700464

UC-EpiCheck-FDA-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 680 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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680 participants in 2 patient groups

Bladder EpiCheck Urine Test

Experimental group

Description:

Bladder EpiCheck Urine Test

Treatment:

Device: Bladder EpiCheck Urine Test

Gold Standard

Active Comparator group

Description:

Cystoscopy and pathology

Treatment:

Procedure: Cystoscopy and pathology