Abstract
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.”
Original language | English |
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Article number | 34 |
Pages (from-to) | 1-7 |
Number of pages | 7 |
Journal | BMC Urology |
Volume | 24 |
Issue number | 1 |
Early online date | 9 Feb 2024 |
DOIs | |
Publication status | E-pub ahead of print - 9 Feb 2024 |
Keywords
- Bladder cancer
- Non-muscle invasive tumor
- URO17®
- Urothelial cancer
- cancer follow-up
- Follow-Up Studies
- Humans
- Middle Aged
- Cystoscopy
- Urinary Bladder Neoplasms/pathology
- Hematuria/diagnosis
- Biomarkers
- Urinary Bladder/pathology
- Aged
- Neoplasm Recurrence, Local/diagnosis