Aim: To examine prospectively the impact of adding a urinary biomarker of bladder cancer (Cxbladder TriageTM, CxbT) to a clinical pathway for investigating haematuria.
Methods: The clinical outcome of 571 patients with haematuria who presented to their general practitioner was reviewed. Outcome measurements included the findings of laboratory tests, imaging, cystoscopies, histology and specialist assessments. The data were used to model a theoretical clinical pathway that involved initial screening using CxbT in combination with imaging, and only test positive patients being referred for specialist assessment and cystoscopy.
Results: All patients underwent cystoscopy and 44 transitional cell carcinomas were diagnosed in the study cohort, with two low-risk cancers missed by CxbT, one of which was also not detected by imaging. When combined, imaging and CxbT had a sensitivity of 97.7% and negative predictive value of 99.8%.
Conclusions: In our series, all significant bladder cancers were diagnosed by imaging and CxbT before cystoscopy was undertaken. The high negative predictive value of this clinical pathway would allow approximately one-third of patients with haematuria to be managed without cystoscopy.