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
Study Type
OBSERVATIONAL
Enrollment
682
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.
Veterans Medical Research Foundation
San Diego, California, United States
Bay Pines Veterans Affairs
Bay Pines, Florida, United States
South Florida Veterans Affairs
Miami, Florida, United States
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
Time frame: 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.
Time frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
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.
Time frame: 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
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.
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James A Haley Veterans' Hospital
Tampa, Florida, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
NWIHCS-Omaha VA Medical Center
Omaha, Nebraska, United States
James J. Peters VAMC
New York, New York, United States
Oklahoma City VA Hospital
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
White River Junction VAMC
White River Junction, Vermont, United States
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.