The Cxbladder Hematuria Clinical Utility Study

Official Title

Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design

Summary:

To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.

Trial Description

Primary Outcome:

• To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder is used in the evaluation

Secondary Outcome:

• To measure the change in total procedure use (and the invasive procedure sub-group) count between control and test arms when Cxbladder is used in the evaluation.
• To measure the proportion of subjects who were ruled out on the test arm when Cxbladder is used in the evaluation
• To measure the number of subjects who were incorrectly diagnosed associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC
• Proportion of subjects (and sub-groups within test and control arms) with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
• To compare the total score of the anxiety and pain level associated with cystoscopy vs Cxbladder by using Patient Result Outcome questionnaire and WIWI(was it worthy it)
• Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.

Randomised two arm pragmatic clinical study to be conducted at multiple sites in US and Canada. The trial will recruit hematuria subjects, presenting to qualified sites (academic, community), who are being evaluated for urothelial carcinoma (UC). Up to 100 consecutive eligible subjects will be recruited per site.

View this trial on ClinicalTrials.gov