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Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.
The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with hematuria undergoing investigation for UC | Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as ≥ 3 red blood cells per high-powered microscopy field for a properly collected urine sample. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cxbladder | Diagnostic Test | The Cxbladder Detect+ test is a molecular diagnostic test. The test consists of six DNA biomarkers and five RNA biomarkers measured in a small volume of urine. is an enhanced version of the Cxbladder Detect test. |
| 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 hematuria | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months) |
| 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 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. | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months). |
| Measure | Description | Time Frame |
|---|---|---|
| To identify whether patients received a UC diagnosis 6- and 24-months post urine sample collection | To identify by records review within six months and up to 24-months after the initial urine sample collection whether the patient received a diagnosis of UC of the bladder and/or upper tract. | The outcome measure will be assessed by 6- and up to 24-months after trial completion. |
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Inclusion Criteria:
Exclusion Criteria:
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This study will be conducted with all hematuria patients who present to an outpatient clinic to undergo clinical assessment including cystoscopy and who fulfil study requirements. Consented eligible patients will attend their scheduled clinic visit and undergo all standard tests as clinically indicated.
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| Name | Affiliation | Role |
|---|---|---|
| Tony Lough, PhD | Pacific Edge Pty Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Medical Research Foundation | San Diego | California | 92161 | United States | ||
| Bay Pines Veterans Affairs |
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| ID | Term |
|---|---|
| D006417 | Hematuria |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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A minimum of 30 mL of urine will be required for the sampling system to function. Two 5 mL aliquots of the collected urine will be transferred to a vacutainer containing a preservative reagent, and couriered to Pacific Edge Diagnostic NZ Laboratories.
| Validation of performance characteristics of Cxbladder tests through sub-group analyses | To validate the performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value) and true negative rate of Cxbladder tests through sub-group analysis (gross hematuria; microhematuria; inflammation), in a VA cohort, for patients with a recent history of hematuria who are undergoing investigative cystoscopy. | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months). |
| 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. | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months). |
| To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy. | To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting. | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months). |
| Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites | To evaluate the performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites, and to the results of the pulished clinical studies by O'Sullivan et al in 2012 and Kavalieris et al in 2015 | The outcome measure will be assessed from enrolment to when a UC diagnosis is made or patient is considered UC negative for this trial (maximum period 24-months) and completed following completion of other similar trials. |
| Bay Pines |
| Florida |
| 33744-8200 |
| United States |
| South Florida Veterans Affairs | Miami | Florida | 33125 | United States |
| James A Haley Veterans' Hospital | Tampa | Florida | 33612-4745 | United States |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | United States |
| NWIHCS-Omaha VA Medical Center | Omaha | Nebraska | 68105 | United States |
| James J. Peters VAMC | New York | New York | 10468-3904 | United States |
| Oklahoma City VA Hospital | Oklahoma City | Oklahoma | 73104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| White River Junction VAMC | White River Junction | Vermont | 05009 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |