Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design
Objective
Primary Objectives: 1. To evaluate the increase in utility defined by the reduction in cystoscopy procedures when Cxbladder is used in the evaluation of hematuria subjects when compared with the satndard of care (SOC). The gold standard for determination of a confirmed clinical diagnosis is cystoscopy confirmed by pathology, plus imaging or any follow-up investigations relating to the visit.
Secondary Objectives: 1. To evaluate the increase in utility defined by the reduction in: a) invasive procedures, b) total procedures (invasive and cystoscopy) when Cxbladder is used in the evaluation of hematuria subjects when compared with the standard of care (SOC).
2. To quantify the 'rule-out' percentage (negative fraction) associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of UC.
3. To quantify the false negative rate (the percentage of the negative fraction incorrectly diagnosed) associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of UC.
4. To quantify the other performance characteristics (sensitivity, specificity, PPV) of Cxbladder signatures including for the detection of high grade / stage UC in subjects.
5. To validate the impact of integrating the Cxbladder test on the quality of life (QoL) of participants, by comparing responses between SOC and test arms.
6. To evaluate equivocal cystoscopy on test and control arms relative to negative biopsy.
7. To evaluate the relative rates of TURBT on test and control arms.
