Abstract
Bladder EpiCheck® (Nucleix Ltd, Israel) is a molecular urine assay detecting DNA methylation alterations associated with bladder cancer. This pilot study aimed to evaluate its diagnostic performance in predicting residual tumor in patients undergoing re-transurethral resection of bladder tumor (reTURB) according to international guidelines. After ethical approval, 79 patients were prospectively enrolled at two academic centers. Voided urine samples were collected before initial TURB and analyzed, generating an EpiScore from 0 to 100, considered positive when ⩾60. Fifty-seven percent of patients showed a positive result and entered the second phase. Twenty-two had an indication for reTURB, and 13 finally underwent surgery with a second preoperative urine test. Among 10 patients with a negative pre-reTURB EpiScore, 9 had no residual tumor and one had Ta high-grade disease. Among 3 patients with a positive pre-reTURB EpiScore, 1 had T1 high-grade cancer and 2 had negative pathology, although 1 developed T1 high-grade disease within 3 months. Sensitivity, specificity, negative predictive value and positive predictive value were 50%, 82%, 90% and 33%, respectively. The high negative predictive value suggests that Bladder EpiCheck® may help identify patients without residual tumor and potentially avoid unnecessary Re-TURB. Larger prospective multicenter studies are required to confirm these findings.
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