The Cxbladder Monitoring Study

Completed

Conditions studied: Urothelial Carcinoma

In brief

The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy. The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.

Key facts

Study ID

NCT02700659

Run by

Pacific Edge Limited

People needed

803

Starts

2013-02-04

Expected to finish

2016-09-23

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed positive diagnosis for primary or recurrent urinary tract UC over the past 2 years.
• Patient is undergoing investigative cystoscopies for the monitoring of recurrence of UC at intervals prescribed by a clinical practitioner
• Patient is 18 years of age or older.

You may not qualify if…

• Prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
• Patient has undergone total bladder cystectomy as treatment for bladder UC

Where it is running

• Urology Centers of Alabama — Homewood, Alabama, United States
• Urology Center of Grove Hill, One Lake Street — New Britain, Connecticut, United States
• Florida Urology Associates — Orlando, Florida, United States
• Idaho Urologic Institute — Meridian, Idaho, United States
• Delaware Valley Urology, LLC — New Jersey, New Jersey, United States
• Premier Medical Group of the Hudson Valley — Kingston, New York, United States
• Weill Cornell Medical College, Department of Urology — New York, New York, United States
• Premier Medical Group of the Hudson Valley — New York, New York, United States
• Premier Medical Group of the Hudson Valley — Newburgh, New York, United States
• Penn State Hershey Medical Center and College of Medicine — Hershey, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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