PO.CL01.21 · 临床研究

使用基于尿液的多重免疫检测Oncuria-Detect检测肉眼血尿患者的膀胱癌

Detection of bladder cancer in patients with gross hematuria using Oncuria-Detect, a urine-based multiplex immunoassay

编号 6513 展板 2 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, Toru Sakatani¹, Yingye Zheng⁸, Zhen Zhang⁹, Charles Joel Rosser¹, 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——膀胱镜检查是评估肉眼血尿患者是否患膀胱癌的标准诊疗方式，血尿是膀胱癌的主要体征。Oncuria-Detect是一种从单次排空尿样本中检测新发膀胱癌的液体活检，展现出良好的性能。方法——为研究Oncuria-Detect（一种多重免疫检测，可检测排空尿液中由10种蛋白组成的尿路上皮癌相关诊断特征）能否在评估肉眼血尿受试者时改善尿路上皮癌的检测。从2016年9月至2025年7月，美国和日本的9家学术、私人执业和医院机构前瞻性地将450名肉眼血尿受试者纳入本尿路上皮癌评估研究。尿路上皮癌的诊断基于膀胱镜（或输尿管镜）检查加活检，此为公认的参考标准。在膀胱镜/输尿管镜评估之前，受试者提供尿样本用于分析Oncuria-Detect和BladderChek（以盲法进行分析）以及尿细胞学。将Oncuria-Detect的性能与BladderChek和尿细胞学进行比较，作为借助膀胱镜/输尿管镜检查和组织学评估检测新发尿路上皮癌的辅助手段。结果——97名受试者被诊断为尿路上皮癌（其中4名为上尿路尿路上皮癌，93名为膀胱尿路上皮癌）。Oncuria-Detect检测在97名癌症受试者中的80名呈阳性，灵敏度为82.6%（95% CI，74.9%-89.6%），特异性为33.3%（95% CI，28.7%-38.7%），校正后阴性预测值（NPV）为88.4%（95% CI，83.8%-93.0%）。BladderChek在97名受试者中的16名呈阳性，灵敏度为16.4%（95% CI，10.0%-23.5%），特异性为99.2%（95% CI，98.0%-100.0%），校正后NPV为82.6%（95% CI，81.5%-83.7%）；而细胞学检测结果在97名受试者中的35名呈阳性，灵敏度为35.7%（95% CI，26.5%-46.1%），特异性为99.7%（95% CI，99.1%-100.0%），校正后NPV为86.1%（95% CI 84.4-88.1）。Oncuria-Detect的灵敏度对低级别81.7%（95% CI，67.2%-94.7%）与高级别82.7%（95% CI，74.2%-90.9%）以及NMIBC 82.9%（95% CI，74.4%-90.8%）与MIBC 79.8%（95% CI，61.3%-94.7%）均保持较高水平。结论——在这项大型前瞻性试验中，Oncuria-Detect在检测新发尿路上皮癌方面的灵敏度显著优于BladderChek和尿细胞学，使其能够有效排除约30%前来接受肉眼血尿评估的个体。

查看英文原文 English abstract

Background - Cystoscopy is standard of care in evaluating patients with gross hematuria for bladder cancer with hematuria being the primary sign of bladder cancer. Oncuria-Detect, a liquid biopsy to detect de novo bladder cancer from a single voided urine sample demonstrated favorable performance. Methods - To investigate whether Oncuria-Detect, a multiplex immunoassay that detects a urothelial cancer associated diagnostic signature composed of 10 proteins in voided urine could improve detection of urothelial cancer while evaluating participants with gross hematuria. From September 2016 through July 2025, 9 academic, private practice, and hospital facilities in the US and Japan prospectively enrolled 450 participants with gross hematuria into this urothelial cancer evaluation study. Diagnosis of urothelial cancer was based on cystoscopy (or ureteroscopy) with biopsy, which is accepted as the reference standard. Prior to the cystoscopic/ureteroscopic evaluation, participants provided a urine sample for analysis of Oncuria-Detect and BladderChek (analyzed in a blinded manner) as well as urine cytology. The performance of Oncuria-Detect was compared with BladderChek and urine cytology as an aid to detect de novo urothelial cancer with cystoscopy/ureteroscopy and histological evaluation. Results - Urothelial cancer was diagnosed in 97 participants (4 of whom had upper tract urothelial carcinoma and 93 with urothelial carcinoma of the bladder). The Oncuria-Detect assay was positive in 80 of 97 participants with cancer resulting in a sensitivity of 82.6% (95% CI, 74.9%-89.6%) with a specificity of 33.3% (95% CI, 28.7%-38.7%) and 88.4% adjusted negative predictive value (NPV) (95% CI, 83.8%-93.0%). BladderChek results were positive in 16 of 97 participants resulting in a sensitivity, 16.4% (95% CI, 10.0%-23.5%) with a specificity of 99.2% (95% CI, 98.0%-100.0%) and 82.6% adjusted NPV (95% CI, 81.5%-83.7%), whereas cytology test results were positive in 35 of 97 participants with a noted sensitivity of 35.7% (95% CI, 26.5%-46.1%) at a specificity of 99.7% (95% CI, 99.1%-100.0%) and 86.1% adjusted NPV (95% CI 84.4-88.1). Oncuria-Detect sensitivity remained high for low-grade 81.7% (95% CI, 67.2%-94.7%) vs . high grade 82.7% (95% CI, 74.2%-90.9%) and NMIBC 82.9% (95% CI, 74.4%-90.8%) vs. MIBC 79.8% (95% CI, 61.3%-94.7%). Conclusions - In this large prospective trial, Oncuria-Detect, had a substantially superior sensitivity compared to both BladderChek and urinary cytology in detecting de novo urothelial cancers, allowing it to effectively rule out approximately 30% of individuals presenting for gross hematuria evaluation.

利益披露 Disclosure

S. Tanaka, None.

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