PO.CL01.21 · 临床研究

使用 Oncuria-Detect 检测镜下血尿患者的膀胱癌：一项国际前瞻性研究的中期分析

Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect, interim analysis of an international prospective study

编号 6514 展板 3 时间 4/21 02:00–05:00 区域 Section 43 主讲 Sunao Tanaka, PhD

分会场 Diagnostic Biomarkers 2

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作者与单位 Authors & Affiliations

Sunao Tanaka¹, Yair Lotan², Makito Miyake³, Edward M. Messing⁴, Arnold I. Chin⁵, Menghan Liu⁶, Ian Pagano⁷, Yingye Zheng⁸, Charles Joel Rosser¹, Zhen Zhang⁹, Hideki Furuya¹

¹Cedars-Sinai Medical Center, Los Angeles, CA,²Associate Professor of Urology, UT Southwestern Medical Ctr., Dallas, TX,³Nara Medical University, Nara, Japan,⁴Chairman & Professor, Dept. of Urology, University of Rochester Cancer Center, Rochester, NY,⁵Assistant Professor, Dept. of Urology, University of California (UCLA), Los Angeles, CA,⁶Fred Hutchinson Cancer Center, Seattle, WA,⁷UHCC, Honolulu, HI,⁸Fred Hutchinson Cancer Research Ctr., Seattle, WA,⁹Associate Professor, Dept. of Pathology & Oncology, Johns Hopkins University School of Medicine, Baltimore, MD

摘要 Abstract

中文摘要

背景 - 镜下血尿在普通人群中的发生率高达 10%，并会引发昂贵的检查以确保不存在膀胱癌。Oncuria-Detect 是一种 10 重免疫测定，通过从单份自排尿样本中生成蛋白质生物标志物特征来检测新发膀胱癌。本报告详述了我们前瞻性研究的中期分析，该研究比较了多重 Oncuria-Detect 测定与单一分析物（即 NMP22）BladderChek 尿液测定以及尿细胞学在识别镜下血尿患者膀胱癌方面的诊断性能。方法 - 自 2018 年 9 月至 2025 年 7 月，美国和日本的 9 家医疗机构前瞻性地将拟定 900 例镜下血尿患者中的 292 例合格患者（约 30%）纳入本研究。膀胱癌诊断参考标准为膀胱镜检查加活检。在膀胱镜检查前，患者提供尿液样本用于 Oncuria-Detect 和 BladderChek 分析（以盲法进行分析）以及尿细胞学检查。结果 - 22 例患者（7.5%）被诊断为膀胱癌。Oncuria-Detect 测定具有以下性能特征：灵敏度 82.0%、特异度 37.8%、校正阴性预测值（NPV）97.5%，而 BladderChek 为（灵敏度 9.3%、特异度 99.6%、校正 NPV 95.4%），细胞学为（灵敏度 44.8%、特异度 99.3%、校正 NPV 97.2%）。在识别早期和晚期癌症方面，Oncuria-Detect 表现出优于 BladderChek 和细胞学的灵敏度。结论 - 在这项国际前瞻性试验的中期分析中，Oncuria-Detect 在对表现为镜下血尿患者进行膀胱癌存在与否的非侵入性评估中表现良好。

查看英文原文 English abstract

Background - Microscopic hematuria occurs in up to 10% of the general population and initiates costly evaluation to ensure no bladder cancer exists. Oncuria-Detect is a 10-plex immunoassay that detects de novo bladder cancer by generating a protein biomarker signature from a single voided urine sample. This report details the interim analysis of our prospective study that compares the diagnostic performance of the multiplex Oncuria-Detect assay to that of the single-analyte ( i.e. , NMP22) BladderChek urine assay and urine cytology for identifying bladder cancer in patients with microscopic hematuria. Methods - From September 2018 through July 2025, 9 medical facilities in the US and Japan prospectively enrolled 292 eligible patients (~30%) of the proposed 900 patients with microscopic hematuria into this study. The bladder cancer diagnostic reference standard was cystoscopy with biopsy. Pre-cystoscopy, patients provided a urine sample for analysis by Oncuria-Detect and BladderChek (analyzed in a blinded manner) as well as urine cytology. Results - Bladder cancer was diagnosed in 22 patients (7.5%). The Oncuria-Detect assay had the following performance characteristics 82.0% sensitivity, 37.8% specificity, 97.5% adjusted negative predictive value (NPV) compared to BladderChek (9.3% sensitivity, 99.6% specificity, 95.4% adjusted NPV) and cytology (44.8% sensitivity, 99.3% specificity, 97.2% adjusted NPV). Oncuria-Detect displayed better sensitivity than BladderChek and cytology for identifying early- and late-stage cancer. Conclusions - In this interim analysis of an international prospective trial, Oncuria-Detect performed favorably in the non-invasive evaluation of bladder cancer presence in patients presenting with microscopic hematuria.

利益披露 Disclosure

S. Tanaka, None.

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