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NCT02647112 Clinical Trial

Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Bladder Cancer Clinical Trial

Official title:
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02647112
Other study ID # UC-EpiCheck-EU-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date December 2020

Study information
Verified date May 2021
Source Nucleix Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1050
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 22 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Bladder EpiCheck
Urine test for the monitoring of bladder cancer recurrence

Locations
Country Name City State
Germany Tubingen University Medical Center Tubingen
Israel Meir Medical Center Kfar Saba
Netherlands AMC Medical Center Amsterdam
Netherlands ZGT Medical Center Hengelo
Netherlands Radboud University Medical Center Nijmegen
Spain Vall D'Hebron Medical Center Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Nucleix Ltd.

Countries where clinical trial is conducted

Germany,  Israel,  Netherlands,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Day 1
Primary 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 Day 1
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