The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy. The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.
Study Type
OBSERVATIONAL
Enrollment
803
Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.
Urology Centers of Alabama
Homewood, Alabama, United States
Urology Center of Grove Hill, One Lake Street
New Britain, Connecticut, United States
Florida Urology Associates
Orlando, 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 recurrent disease.
Time frame: The outcome measure will be assessed by 6 months after trial completion.
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.
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: 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 NMP22 ELISA Assay.
Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 ELISA, 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: The outcome measure will be assessed by 6 months after trial completion.
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Idaho Urologic Institute
Meridian, Idaho, United States
Delaware Valley Urology, LLC
New Jersey, New Jersey, United States
Premier Medical Group of the Hudson Valley
Kingston, New York, United States
Weill Cornell Medical College, Department of Urology
New York, New York, United States
Premier Medical Group of the Hudson Valley
New York, New York, United States
Premier Medical Group of the Hudson Valley
Newburgh, New York, United States
Penn State Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, United States
...and 1 more locations
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.
Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 BladderChek, 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: The outcome measure will be assessed by 6 months after trial completion.