Efficacy and Utility of Cxbladder Tests in Hematuria Patients
Study Details
Study Description
Brief Summary
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Multi-site recruitment of patients in Veterans Affairs.Target number of participants up to four sites is around 450 sequentially recruited patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: Cxbladder
The Cxbladder Detect test, developed by Pacific Edge Ltd (O'Sullivan 2012; Holyoake 2008; National Health Committee 2015b) is a molecular diagnostic test, which consists of five mRNA transcripts measured in a small volume of urine.
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Outcome Measures
Primary Outcome Measures
- 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 hematuria
- 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. [Time Frame: 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
- 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.
- To compare the theoretical clinical outcome of patients tested using Cxbladder tests [The outcome measure will be assessed by 6 months after trial completion.]
To compare the theoretical clinical outcome of patients tested using Cxbladder tests in combination (Triage followed by Detect and / or Resolve) 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.
- 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. [The outcome measure will be assessed by 6 months after trial completion.]
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.
- Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites [The outcome measure will be assessed by 6 months after trial completion.]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
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Able to provide a voided urine sample of the required minimum volume
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Able to give written consent
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Able and willing to comply with study requirements
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Aged 18 years or older
Exclusion Criteria:
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Prior history of bladder malignancy, prostate or renal cell carcinoma
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Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
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Previous alkylating based chemotherapy
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Known Pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Veterans Medical Research Foundation | San Diego | California | United States | 92161 |
| 2 | Minneapolis VA Health Care System | Minneapolis | Minnesota | United States | 55417 |
| 3 | NWIHCS-Omaha VA Medical Center | Omaha | Nebraska | United States | 68105 |
| 4 | Oklahoma City VA Hospital | Oklahoma City | Oklahoma | United States | 73104 |
| 5 | Medical University of South Carolina | Charleston | South Carolina | United States | 29401 |
Sponsors and Collaborators
- Pacific Edge Limited
Investigators
- Study Chair: Tony Lough, PhD, Pacific Edge Pty Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CXB/2019/VA