The Cxbladder Monitoring Study

Completed

• Conditions: Urothelial Carcinoma
• Interventions: Other: Cxbladder

• Registration Number: NCT02700659
• Lead Sponsor: Pacific Edge Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-04
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-07
• Primary Completion: 2016-09-23
• Study Completion: 2016-09-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 803

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UC monitoring patients	Cxbladder	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.

Primary Outcome Measures

Name	Time	Method
Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.	The outcome measure will be assessed by 6 months after trial completion.
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.	The outcome measure will be assessed by 6 months after trial completion.	The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.

Secondary Outcome Measures

Name	Time	Method
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.	The outcome measure will be assessed by 6 months after trial completion.	Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.	The outcome measure will be assessed by 6 months after trial completion.	Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 BladderChek, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay.	The outcome measure will be assessed by 6 months after trial completion.	Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 ELISA, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.

Trial Locations

Locations (9)

Urology Center of Grove Hill, One Lake Street; 🇺🇸 New Britain, Connecticut, United States

Weill Cornell Medical College, Department of Urology; 🇺🇸 New York, New York, United States

Idaho Urologic Institute; 🇺🇸 Meridian, Idaho, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Delaware Valley Urology, LLC; 🇺🇸 New Jersey, New Jersey, United States

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

Penn State Hershey Medical Center and College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States

Florida Urology Associates; 🇺🇸 Orlando, Florida, United States

Premier Medical Group of the Hudson Valley; 🇺🇸 Newburgh, New York, United States