The Cxbladder Monitoring Study

Pacific Edge

Status: Completed

Conditions: Urothelial Carcinoma

Treatments: Other: Cxbladder

Study type: Observational

Funder types: Industry

Identifiers

NCT02700659

Cxb-012-EXP-013

Details and patient eligibility

About

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.

Enrollment: 803 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

803 participants in 1 patient group

UC monitoring patients

Description:

Patients undergoing investigative cystoscopy for the detection of urothelial carcinoma as part of a standard-of-care schedule of investigations. All patients will have urine samples taken and analyzed for NMP22 ELISA, NMP22 BladderChek, urine cytology and Cxbladder. No results for any tests under evaluation in this study are provided to the clinician for diagnostic purposes.

Treatment:

Other: Cxbladder