Phase 2 Study of Esophageal String Test in Diagnosing Eosinophilic Esophagitis

食管拉线试验诊断嗜酸性食管炎的二期研究

• 批准号: 8721829
• 负责人: Steven Jules Ackerman
• 金额: $ 39.8万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8721829
• 关键词: Phase; Study; Esophageal; String; Test

DESCRIPTION (provided by applicant): Eosinophilic esophagitis (EoE) is a rare disease of children and adults characterized by symptoms such as nausea, vomiting, abdominal pain, dysphagia, and food impaction, that occur in conjunction with esophageal eosinophilia. To date, the only method to make the diagnosis and follow treatment responses in EoE is invasive endoscopy with biopsy. While endoscopy is generally safe, an accurate, less invasive, inexpensive, comprehensive and durable test is needed to determine therapeutic efficacy. To address this need, the investigator proposes the use of a novel application of an existing technology, the Enterotest ?(a string based test used to detect intestinal Giardiasis), to measure esophageal inflammation (herein termed the Esophageal String Test or EST). The investigator states that preliminary data provide proof-of-principle for the ability of ESTs to capture esophageal inflammatory mediators in luminal samples from patients affected with eosinophilic esophagitis, demonstrating that: (1) levels of eosinophil-derived granule proteins in esophageal mucosal biopsies correlate with the levels quantitated in the EST-captured samples, i.e., levels in luminal secretions captured by the EST correlate with mucosal inflammation, and (2) these luminal biomarkers of eosinophilic inflammation significantly correlate with EoE disease activity. According to the investigator these findings support the use of ESTs as novel minimally invasive instruments to monitor therapeutic efficacy in eosinophilic esophagitis. The Specific Aims of the proposed Phase 2, multicenter study in 660 children and adults are to: (1) identify an eosinophilic esophagitis biomarker panel that will improve the sensitivity and specificity of the EST for monitoring disease activity, and () validate the ability of the EST esophagitis biomarker panel to monitor therapeutic efficacy in 1-hour sampling time. The investigator states that preliminary data demonstrate the feasibility of using the EST in both children and adults with EoE to measure disease activity (esophageal inflammation) in an overnight (12-hour) test, and shorter time periods, currently performed before a scheduled endoscopy with biopsy. In this project investigators propose to shorten this time frame to a 1-hour test, a clinically relevant time point that is believed to facilitate use an potential impact in the outpatient clinic setting.

描述（由申请人提供）： 嗜酸性粒细胞性食管炎（EoE）是一种罕见的疾病，儿童和成人的症状，如恶心，呕吐，腹痛，吞咽困难，食物嵌塞，发生与食管嗜酸性粒细胞增多症。迄今为止，唯一的方法，使诊断和后续治疗反应，在EoE是侵入性内镜活检。虽然内窥镜检查通常是安全的，但需要一种准确，微创，廉价，全面和持久的测试来确定治疗效果。 为了解决这一需要，研究人员建议使用一种新的应用现有的技术，肠试验？（用于检测肠贾第虫病的基于线的测试），以测量食管炎症（本文称为食管线测试或EST）。研究者表示，初步数据为EST捕获嗜酸性粒细胞性食管炎患者管腔样本中食管炎症介质的能力提供了原理证明，表明：（1）食管粘膜活检中嗜酸性粒细胞来源的颗粒蛋白水平与EST捕获样本中定量的水平相关，即，由EST捕获的管腔分泌物中的水平与粘膜炎症相关，和（2）嗜酸性炎症的这些管腔生物标志物与EoE疾病活动显著相关。据调查人员称， 研究结果支持使用EST作为新的微创工具来监测嗜酸性食管炎的治疗效果。在660名儿童和成人中进行的拟定II期、多中心研究的具体目的是：（1）确定一种嗜酸性食管炎生物标志物组，该生物标志物组将提高EST监测疾病活动的灵敏度和特异性，以及（）验证EST食管炎生物标志物组在1小时采样时间内监测疗效的能力。研究者指出，初步数据证明了在儿童和成人EoE患者中使用EST在夜间（12小时）测试中测量疾病活动性（食管炎症）的可行性，目前在计划的内镜检查和活检之前进行的时间较短。在本项目中，研究者建议将该时间范围缩短为1小时测试，这是一个临床相关的时间点，被认为有助于在门诊诊所环境中产生潜在影响。