The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma

Completed · Not applicable

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT02700464

Run by

Nucleix Ltd.

People needed

680

Starts

2016-09-01

Expected to finish

2020-07-01

Last updated by the study team

2021-05-04

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
• 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

You may not qualify if…

• Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma

Where it is running

• 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

Full record on ClinicalTrials.gov

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