Spots Global Cancer Trial Database for The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
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Trial Identification
Brief Title: The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
Official Title: The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
Study ID: NCT02700464
Conditions
Study Description
Brief Summary: Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.
Detailed Description: 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 This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.
Keywords
Eligibility
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Shmulik Adler, MSc
Affiliation: Nucleix Ltd.
Role: STUDY_DIRECTOR
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