Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

• Sponsor: Nucleix Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02647112
• Collaborator: (none)
• Enrollment: 1,050
• Locations: 6
• Arms: 2
• Duration (Months): 60
• Patients Per Site: 175
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Other: Bladder EpiCheck	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1050 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tubingen University Medical Center	Tubingen		Germany
2	Meir Medical Center	Kfar Saba		Israel
3	AMC Medical Center	Amsterdam		Netherlands
4	ZGT Medical Center	Hengelo		Netherlands
5	Radboud University Medical Center	Nijmegen		Netherlands
6	Vall D'Hebron Medical Center	Barcelona		Spain

Sponsors and Collaborators

• Nucleix Ltd.

Investigators

• Study Director: Shmulik Adler, Nucleix Ltd.
• Principal Investigator: Fred Witjes, Prof., Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nucleix Ltd.
• ClinicalTrials.gov Identifier: NCT02647112
• Other Study ID Numbers: UC-EpiCheck-EU-01
• First Posted: Jan 6, 2016
• Last Update Posted: May 4, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Nucleix Ltd.: Bladder cancer; Urine; Methylation
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Study Results

No Results Posted as of May 4, 2021