PURPOSE Alternative, noninvasive, cost-effective methods to complement or serve as substitutes to current standard-of-care (SOC) procedures in NMIBC follow-up are needed. Uromonitor is a urine biomarker test detecting bladder cancer recurrence through the screening of TERT, FGFR3, and KRAS hotspot mutations. The aim of this study was to assess Uromonitor performance by comparing it with the current SOC methods. MATERIALS AND METHODS Four hundred thirty-nine patients with 528 NMIBC surveillances were enrolled in this study. All patients underwent SOC methods and provided a urine sample for Uromonitor analysis before undergoing cystoscopy. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for recurrence and compared with the gold-standard cystoscopy plus transurethral resection of bladder tumor histopathology. RESULTS Uromonitor displayed a sensitivity of 87% (95% CI, 74-95), with only 6 of 47 recurrences failing to be detected; specificity of 99% (98-100); PPV of 93% (82-98); and a NPV of 99% (97-99). Cystoscopy showed a total of 22 false positives (32%) not confirmed by transurethral resection of bladder tumor, whereas Uromonitor presented only 3 positive tests where no lesions were found. Overall recurrence rate was 8.9% (n = 47) among 528 total screenings. Sensitivity, specificity, PPV, and NPV values for Uromonitor remained high across all NMIBC grades and stages. CONCLUSIONS Uromonitor represents a reliable tool in the detection of NMIBC recurrence in patients undergoing routine surveillance, regardless of stage and grade. To our knowledge, this is the largest single-center study assessing Uromonitor's performance, thus validating its usefulness in clinical practice.

中文翻译：

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Uromonitor：非肌层浸润性膀胱癌患者监测中的尿液生物标志物的临床验证和性能评估。


目的 在 NMIBC 随访中，需要替代、无创、具有成本效益的方法来补充或替代当前的护理标准 （SOC） 程序。Uromonitor 是一种尿液生物标志物测试，通过筛查 TERT、FGFR3 和 KRAS 热点突变来检测膀胱癌复发。本研究的目的是通过与当前的 SOC 方法进行比较来评估 Uromonitor 的性能。材料和方法 本研究纳入了 439 例患者，共 528 次 NMIBC 监测。所有患者均接受 SOC 方法，并在接受膀胱镜检查前提供尿液样本用于 Uromonitor 分析。计算复发的敏感性、特异性、阳性预测值 （PPV） 和阴性预测值 （NPV），并与金标准膀胱镜检查加经尿道膀胱肿瘤组织病理学切除术进行比较。结果 Uromonitor 的灵敏度为 87% （95% CI，74-95），47 例复发中只有 6 例未被检测到;特异性为 99% （98-100）;PPV 为 93% （82-98）;NPV 为 99% （97-99）。膀胱镜检查显示共有 22 例假阳性 （32%） 未通过经尿道膀胱肿瘤切除术确认，而 Uromonitor 仅提供 3 例阳性检测，未发现病变。在 8.9 例筛查中，总体复发率为 47% （n = 528）。Uromonitor 的敏感性、特异性、PPV 和 NPV 值在所有 NMIBC 分级和阶段中都保持较高水平。结论 Uromonitor 是检测接受常规监测的患者 NMIBC 复发的可靠工具，无论分期和分级如何。据我们所知，这是评估 Uromonitor 性能的最大单中心研究，从而验证了其在临床实践中的有用性。