Hematuria, Urothelial Carcinoma
Conditions
Brief summary
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
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. 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
Interventions
DIAGNOSTIC_TESTCxbladder
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.
Sponsors
Pacific Edge Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Able to provide a voided urine sample of the required minimum volume * Able to give written consent * Able and willing to comply with study requirements * Aged 18 years or older
Exclusion criteria
* Prior history of bladder malignancy, prostate or renal cell carcinoma * Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection * Previous alkylating based chemotherapy * Known Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test. | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months) | 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. | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months). | 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
| Measure | Time frame | Description |
|---|---|---|
| To identify whether patients received a UC diagnosis 6- and 24-months post urine sample collection | The outcome measure will be assessed by 6- and up to 24-months after trial completion. | 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. |
| Validation of performance characteristics of Cxbladder tests through sub-group analyses | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months). | 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. |
| Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology. | From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months). | 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 signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy. | 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 (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 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. | 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 |
Countries
United States
Contacts
STUDY_CHAIRTony Lough, PhD
Pacific Edge Pty Ltd
Outcome results
None listed