The role of URO17® in diagnosis and follow up of bladder cancer patients

Objective to evaluate the role of urinary URO17® biomarker in the detection of urothelial tumors in haematuria patients and the detection of recurrence in non-muscle invasive bladder urothelial tumors.

Materials and methods Our study was formed of two cohorts of patients, group I represents patients presenting with haematuria ( n  = 98), while group II represents patients with known non-muscle invasive bladder cancers on their scheduled follow up cystoscopic investigation ( n  = 51).

For both groups, patients were asked to provide urine samples before cystoscopy, either primary as part of the haematuria investigation or as a scheduled follow-up.

Urine samples were sent anonymously for standard urine cytology and URO17® biomarker immunostaining.

Results were compared to cystoscopic findings using Chi-square analysis and Fisher’s exact test ( P  < 0.05).

Results Group I was formed of 98 patients, with an average age of 60 years.

URO17® showed 100% sensitivity and 96.15% specificity with a negative predictive value (NPV) of 100 and a positive predictive value (PPV) of 95.83.

The results showed statistical significance with P value < 0.001.

Group II was formed of 51 patients, with an average age of 75 years.

URO17® was shown to have a sensitivity of 85.71% and NPV of 95.45.

Eleven patients of group II were on scheduled BacillusCalmette-Guerin (BCG) and another 5 received Mitomycin C (MMC).

The overall results of both groups combined ( n  = 149) showed statistical significance between flexible cystoscopy results and the results of urinary URO17® and urine cytology.

Conclusion URO17® has a potential to be a reliable test for diagnosis and follow up of urothelial cancer patients and a screening tool adjunct to flexible cystoscopy.

Trial Registration Not applicable as the current study is not a clinical trial, as per according to the National Institutes of Health, “studies that involve a comparison of methods and that do not evaluate the effect of the interventions on the participant do not meet the NIH clinical trial definition.”