Immunocytochemical detection of minichromosome maintenance protein 2 as a potential urinary-based marker of bladder cancer: A prospective observational study

Introduction: Numerous biomarkers have been investigated for the diagnosis and follow-up of patients with bladder cancer, but none has achieved desirable acceptability. In the search of biomarkers, minichromosome maintenance protein 2 (MCM2), a cell cycle regulatory protein, was investigated and the preliminary results were promising. Hence, we conducted a study to investigate the role of immunocytochemical (ICC) detection of MCM2 in voided urinary samples of patients with bladder cancer in an Indian population. Materials and Methods: A prospective comparative observational study was performed. One hundred and fifty patients with a mass lesion in the bladder and 100 controls were enrolled in this prospective study from June 2017 to–December 2018. Fifty-milliliter of voided urine sample was collected and processed for ICC staining of MCM2. Results: Fifty, 100, and 200 positive MCM2 cells as a cutoff value has shown a sensitivity of 87.33% (80.93%–92.20%), 84.67% (77.89%–90.02%), and 80.67% (73.43%–86.65%), respectively. The specificity of 50, 100, and 200 positive MCM2 cells was 97% (91.48%–99.38%), 99% (94.55%–99.97%), and 100% (96.38%–100.0%), respectively. Conclusion: ICC detection of MCM2 in voided urinary samples has good sensitivity and specificity for the detection of bladder cancer. Hence, it can be used as a potential marker for the detection of bladder cancer.