Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Nucleix Ltd.1,050 enrolled

Overview

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

1,050

Conditions

Bladder Cancer

Interventions

Bladder EpiCheckOTHER

Urine test for the monitoring of bladder cancer recurrence

Eligibility

Sex: ALLMin age: 22 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma * Has all urothelial cell carcinoma tumor resected within the past 12 months * Has a plan for cystoscopic surveillance Exclusion Criteria: * Planning to undergo radical cystectomy or chemotherapy-radiation for UCC

Locations (6)

Tubingen University Medical Center

Tübingen, Germany

Meir Medical Center

Kfar Saba, Israel

AMC Medical Center

Amsterdam, Netherlands

ZGT Medical Center

Hengelo, Netherlands

Outcomes

Primary Outcomes

Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)

the proportion of positives that are correctly identified as such by the gold standard

Time frame: Day 1

Specificity (the proportion of negatives that are correctly identified as such by the gold standard)

the proportion of negatives that are correctly identified as such by the gold standard

Time frame: Day 1

Data from ClinicalTrials.gov

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