Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Other: Bladder EpiCheck

• Registration Number: NCT02647112
• Lead Sponsor: Nucleix Ltd.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1050

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

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Exclusion Criteria

• Planning to undergo radical cystectomy or chemotherapy-radiation for UCC

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bladder EpiCheck	Bladder EpiCheck	Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology

Primary Outcome Measures

Name	Time	Method
Specificity (the proportion of negatives that are correctly identified as such by the gold standard)	Day 1	the proportion of negatives that are correctly identified as such by the gold standard
Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)	Day 1	the proportion of positives that are correctly identified as such by the gold standard

Trial Locations

Locations (6)

Tubingen University Medical Center; 🇩🇪 Tubingen, Germany

ZGT Medical Center; 🇳🇱 Hengelo, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Vall D'Hebron Medical Center; 🇪🇸 Barcelona, Spain

AMC Medical Center; 🇳🇱 Amsterdam, Netherlands

Meir Medical Center; 🇮🇱 Kfar Saba, Israel