The Cxbladder Monitoring Study

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)

Conditions
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Urothelial Carcinoma

Intervention / Treatment
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* Other: Cxbladder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UC monitoring patients<br>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. | Other: Cxbladder<br>* Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | The outcome measure will be assessed by 6 months after trial completion. | 
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology. | 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. | The outcome measure will be assessed by 6 months after trial completion. | 
| Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay. | 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. | The outcome measure will be assessed by 6 months after trial completion. | 
| Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay. | 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. | The outcome measure will be assessed by 6 months after trial completion. |