The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
NCT ID: NCT02700464
Last Updated: 2021-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
680 participants
INTERVENTIONAL
2016-09-30
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
DOUBLE
Study Groups
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Bladder EpiCheck Urine Test
Bladder EpiCheck Urine Test
Bladder EpiCheck Urine Test
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer
Gold Standard
Cystoscopy and pathology
Cystoscopy and pathology
Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy
Interventions
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Bladder EpiCheck Urine Test
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer
Cystoscopy and pathology
Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy
Eligibility Criteria
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Inclusion Criteria
* Has had all urothelial cell carcinoma tumor resected within the past 12 months
* Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
* Able to provide legally effective informed consent
* Able to produce 45mL of urine
Exclusion Criteria
22 Years
ALL
No
Sponsors
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Nucleix Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shmulik Adler, MSc
Role: STUDY_DIRECTOR
Nucleix Ltd.
Locations
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The Urology Center of Colorado
Denver, Colorado, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Michigan Institute of Urology, P.C.
Troy, Michigan, United States
Metro Urology
Woodbury, Minnesota, United States
Urological Surgeons of Long Island
Garden City, New York, United States
Duke University Health System
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Urology San Antonio
San Antonio, Texas, United States
University Of Washington
Seattle, Washington, United States
UHN, Princess Margret Cancer center
Toronto, Ontario, Canada
Countries
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Other Identifiers
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UC-EpiCheck-FDA-01
Identifier Type: -
Identifier Source: org_study_id
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