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Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02647112
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Nucleix Ltd.

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 2015
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Sensitivity (the proportion of positives that are correctly identified as such by the gold standard) [ Time Frame: 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) [ Time Frame: Day 1 ]
    the proportion of negatives that are correctly identified as such by the gold standard


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647112


Locations
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Germany
Tubingen University Medical Center
Tubingen, Germany
Israel
Meir Medical Center
Kfar Saba, Israel
Netherlands
AMC Medical Center
Amsterdam, Netherlands
ZGT Medical Center
Hengelo, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Spain
Vall D'Hebron Medical Center
Barcelona, Spain
Sponsors and Collaborators
Nucleix Ltd.
Investigators
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Study Director: Shmulik Adler Nucleix Ltd.
Principal Investigator: Fred Witjes, Prof. Radboud University Medical Center
More Information
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Responsible Party: Nucleix Ltd.
ClinicalTrials.gov Identifier: NCT02647112    
Other Study ID Numbers: UC-EpiCheck-EU-01
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nucleix Ltd.:
Bladder cancer
Urine
Methylation
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases