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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC monitoring patients | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cxbladder | Other | Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects were recruited from community and referral centres. Patients were under surveillance for recurring urothelial carcinoma monitoring, and undergoing all standard of care, including investigative cystoscopy.
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| Name | Affiliation | Role |
|---|---|---|
| Paul J O'Sullivan, PhD | Pacific Edge Limited | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| Urology Center of Grove Hill, One Lake Street |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32700139 | Derived | Lough T, Luo Q, O'Sullivan P, Chemasle C, Stotzer M, Suttie J, Darling D. Clinical Utility of Cxbladder Monitor for Patients with a History of Urothelial Carcinoma: A Physician-Patient Real-World Clinical Data Analysis. Oncol Ther. 2018 Jun;6(1):73-85. doi: 10.1007/s40487-018-0059-5. Epub 2018 Apr 19. |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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De-identified, consented participant samples of between 5mL and 15 mL of urine, stabilized in the proprietary Cxbladder liquid, will be stored at -80ºC for further urinary diagnostic assay development and improvement.
| 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. |
| New Britain |
| Connecticut |
| 06052 |
| United States |
| Florida Urology Associates | Orlando | Florida | 32803 | United States |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | United States |
| Delaware Valley Urology, LLC | New Jersey | New Jersey | 08054 | United States |
| Premier Medical Group of the Hudson Valley | Kingston | New York | 12401 | United States |
| Weill Cornell Medical College, Department of Urology | New York | New York | 10065 | United States |
| Premier Medical Group of the Hudson Valley | New York | New York | 12061 | United States |
| Premier Medical Group of the Hudson Valley | Newburgh | New York | 12550 | United States |
| Penn State Hershey Medical Center and College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |