An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pacific Edge Limited
- Enrollment
- 682
- Locations
- 19
- Primary Endpoint
- 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.
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Cxbladder (Diagnostic Test)
Outcomes
Primary Outcomes
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: 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.
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
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 hematuria
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Time Frame: 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.
Time Frame: 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 Outcomes
- 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.)
- 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.)
- To compare the theoretical clinical outcome of patients tested using Cxbladder tests(The outcome measure will be assessed by 6 months after trial completion.)
- 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 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.)
- 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).)
- 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).)
- 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).)
- 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.)