Abstract

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• Human telomerase reverse transcriptase (hTERT) mRNA expression has been considered a surrogate marker for telomerase activity based on its parallel detection in urological malignancies, including transitional cell carcinoma (TCC) of the bladder. The objective of this study was to prospectively evaluate the diagnostic performance of urine hTERT mRNA marker and urine cytology in the detection of bladder cancer. The multiplex hTERT/GAPDH (glyceraldehyde-3-phosphate dehydrogenase) reverse transcription polymerase chain reaction (RT-PCR) assay was employed to assess hTERT mRNA expression in urine sediments from 43 patients with clinically apparent TCC undergoing transurethral resection. Tumor grade and pathological stage were determined. The results of urine cytology were compared with urine hTERT mRNA expression. The control group consisted of 46 age-matched healthy volunteers without known urinary tract disease. The sensitivity of hTERT mRNA expression marker in the detection of bladder cancer was significantly better than urine cytology (95% versus 65%, p<0.001). The hTERT mRNA was detected with high sensitivity in both low and high grade tumors, and in superficial and invasive phenotypes. No correlation was seen between hTERT mRNA and the histopathological grade and stage. The specificity of urinary hTERT mRNA marker was 93.5%. The detection of hTERT mRNA expression in urine was a highly sensitive marker for the diagnosis of TCC of the bladder in this study. This urine-based marker shows promise as a non-invasive adjunct to cystoscopy in patients undergoing bladder tumor surveillance.