Investigation of Atypical Cell Parameter in the Surveillance of Patients with NMIBC; Initial Outcomes of a Single Center Prospective Study

Objective: To investigate how well the Sysmex automated urine-analyzer's atypical-cell parameter can predict oncological outcomes when compared to cytology and pathology data in the follow-up of NMIBC patients. Material and Methods: We prospectively collected clinical data from 273 patients who underwent cystoscopic examination due to benign and malign reasons in our center between June 2020 and March 2021. Patients were divided into 2 groups. (Group-1: Patients with no previous diagnosis of bladder cancer(BC), Group-2: Patients with previously diagnosed NMIBC). The a typical-cell parameter was determined by studying the urine sample given by the patient for urinalysis. The atypical-cell parameter's sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) were assessed. Results: A total of 76(41.1%) patients underwent diagnostic procedures (Group-1) and remaining 109(58.9%) patients were NMIBC patients (Group-2) who subjected to control cystoscopy on follow-up. BC was detected in 70 patients, 28 of whom were newly diagnosed (Group-1). Remaining 42 patients had recurrence during their follow-up (Group-2). Atypical cell values of 70 patients with BC were determined to be statistically significantly higher than those without malignancy. In Group-2, median atypical-cell values for those with no malignancy, those with low-grade BC reccurrence, and those with high-grade BC recurrence were 0.00(IQR:0.00-0.80), 0.25(IQR:0.10celcius1.10) and 1.20(IQR:0.70-2.15), respectively (p<0.001). For a cut-off of 0.1 atypical cells/mu L, sensitivity and specificity were measured as 83.33% and 53.73%, respectivel (AUC:0.727;p-value<0.001). Conclusion: Atypical-cell parameter of the Sysmex-UF-5000 automated urine-analyzer is a newly introduced research parameter. The results of this study are promising. Based on our results, we presume that the atypical-cell parameter may be used in surveillance of the NMIBC patients. Multi-center studies with larger patient populations are required to prove its efficacy.

Automated summary

The study investigates the predictive capability of the Sysmex automated urine-analyzer's atypical-cell parameter compared to cytology and pathology data in the follow-up of NMIBC patients. Clinical data from 273 patients who underwent cystoscopic examination were prospectively collected. The atypical-cell parameter showed promising results in predicting oncological outcomes and could potentially be used in surveillance of NMIBC patients. Multi-center studies with larger patient populations are needed to further validate its efficacy.