Back to resultsUtility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bladder EpiCheck
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer focused on measuring Bladder cancer, Urine, Methylation
Eligibility Criteria
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
Sites / Locations
- Tubingen University Medical Center
- Meir Medical Center
- AMC Medical Center
- ZGT Medical Center
- Radboud University Medical Center
- Vall D'Hebron Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bladder EpiCheck
Practice of medicine
Arm Description
Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology
Practice of medicine including cystoscopy and cytology
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02647112
Brief Title
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma
Official Title
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nucleix Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder cancer, Urine, Methylation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
1050 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bladder EpiCheck
Arm Type
Experimental
Arm Description
Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology
Arm Title
Practice of medicine
Arm Type
No Intervention
Arm Description
Practice of medicine including cystoscopy and cytology
Intervention Type
Other
Intervention Name(s)
Bladder EpiCheck
Intervention Description
Urine test for the monitoring of bladder cancer recurrence
Primary Outcome Measure Information:
Title
Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)
Description
the proportion of positives that are correctly identified as such by the gold standard
Time Frame
Day 1
Title
Specificity (the proportion of negatives that are correctly identified as such by the gold standard)
Description
the proportion of negatives that are correctly identified as such by the gold standard
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmulik Adler
Organizational Affiliation
Nucleix Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fred Witjes, Prof.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tubingen University Medical Center
City
Tubingen
Country
Germany
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Facility Name
AMC Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
ZGT Medical Center
City
Hengelo
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Facility Name
Vall D'Hebron Medical Center
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma
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