Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

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

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

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: Bladder EpiCheck

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 Type: Interventional
• Enrollment (Actual): 1050
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tubingen, Germany
    • Tubingen University Medical Center
• Israel
  • Kfar Saba, Israel
    • Meir Medical Center
• Netherlands
  • Amsterdam, Netherlands
    • AMC Medical Center
  • Hengelo, Netherlands
    • ZGT Medical Center
  • Nijmegen, Netherlands
    • Radboud University Medical Center
• Spain
  • Barcelona, Spain
    • Vall D'Hebron Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bladder EpiCheck; Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology	Other: Bladder EpiCheck; Urine test for the monitoring of bladder cancer recurrence
NO_INTERVENTION: Practice of medicine; Practice of medicine including cystoscopy and cytology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nucleix Ltd.
• Investigators: Principal Investigator: Fred Witjes, Prof., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (ESTIMATE): January 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Bladder cancer; Urine; Methylation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
• Other Study ID Numbers: UC-EpiCheck-EU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO