多中心、前瞻性研究：基于非内镜生物标志物检测 Barrett 食管和食管腺癌。
Multicenter, Prospective Trial of Nonendoscopic Biomarker-Driven Detection of Barrett's Esophagus and Esophageal Adenocarcinoma.
机构信息
Department of Medicine, Case Western Reserve University, and University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Lucid Diagnostics, New York, New York, USA.
出版信息
Am J Gastroenterol. 2024 Nov 1;119(11):2206-2214. doi: 10.14309/ajg.0000000000002850. Epub 2024 Apr 30.
INTRODUCTION
Preliminary data suggest that an encapsulated balloon (EsoCheck), coupled with a 2 methylated DNA biomarker panel (EsoGuard), detects Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) with high accuracy. The initial assay requires sample freezing upon collection. The purpose of this study was to assess a next-generation EsoCheck sampling device and EsoGuard assay in a much-enlarged multicenter study clinically enhanced by using a Clinical Laboratory Improvement Amendments of 1988-compliant assay and samples maintained at room temperature.
METHODS
Cases with nondysplastic BE (NDBE), dysplastic BE (indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia), EAC, junctional adenocarcinoma, plus endoscopy controls without esophageal intestinal metaplasia, were prospectively enrolled. Medical assistants at 6 institutions delivered the encapsulated balloon per orally with inflation in the stomach. The inflated balloon sampled the distal 5 cm of the esophagus and then was deflated and retracted into the capsule, preventing sample contamination. EsoGuard bisulfite sequencing assayed levels of methylated vimentin and methylated cyclin A1.
RESULTS
A total of 243 evaluable patients-88 cases (median age 68 years, 78% men, 92% White) and 155 controls (median age 57 years, 41% men, 88% White)-underwent adequate EsoCheck sampling. The mean procedural time was approximately 3 minutes. Cases included 31 with NDBE, 16 with indefinite for dysplasia/low-grade dysplasia, 23 with high-grade dysplasia, and 18 with EAC/junctional adenocarcinoma. Thirty-seven NDBE and dysplastic BE cases (53%) were short-segment BE (<3 cm). Overall sensitivity was 85% (95% confidence interval 0.78-0.93) and specificity was 85% (95% confidence interval 0.79-0.90). Sensitivity for NDBE was 84%. EsoCheck/EsoGuard detected 100% of cancers (n = 18).
DISCUSSION
EsoCheck/EsoGuard demonstrated high sensitivity and specificity in detecting BE and BE-related neoplasia.
简介
初步数据表明，一种封装的气球（EsoCheck），结合 2 个甲基化 DNA 生物标志物面板（EsoGuard），可以非常准确地检测 Barrett 食管（BE）和食管腺癌（EAC）。最初的检测需要在收集时对样本进行冷冻。本研究的目的是评估下一代 EsoCheck 采样装置和 EsoGuard 检测方法，该方法在经过临床增强后，采用符合 1988 年临床实验室改进修正案的检测方法和室温下保存的样本，在一个更大的多中心研究中进行评估。
方法
前瞻性纳入非发育性 BE（NDBE）、发育性 BE（不确定发育不良、低级别发育不良、高级别发育不良）、EAC、交界性腺癌，以及无食管肠上皮化生的内镜对照患者。6 家机构的医疗助理通过口服将封装的气球送入胃中，并使其充气。膨胀的气球采集食管远端 5cm 的样本，然后放气并收回胶囊中，防止样本污染。EsoGuard 亚硫酸氢盐测序检测甲基化波形蛋白和甲基化细胞周期蛋白 A1 的水平。
结果
共有 243 例可评估患者（88 例，中位年龄 68 岁，78%为男性，92%为白人）和 155 例对照（中位年龄 57 岁，41%为男性，88%为白人）进行了充分的 EsoCheck 采样。平均手术时间约为 3 分钟。病例包括 31 例 NDBE、16 例不确定发育不良/低级别发育不良、23 例高级别发育不良和 18 例 EAC/交界性腺癌。37 例 NDBE 和发育性 BE 病例（53%）为短节段 BE（<3cm）。总体敏感性为 85%（95%置信区间 0.78-0.93），特异性为 85%（95%置信区间 0.79-0.90）。NDBE 的敏感性为 84%。EsoCheck/EsoGuard 检测到 100%的癌症（n=18）。
讨论
EsoCheck/EsoGuard 对 Barrett 食管和 BE 相关肿瘤的检测具有较高的敏感性和特异性。
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