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; 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）： 嗜酸性食管炎（EOE）是一种罕见的儿童和成人疾病，其特征是诸如恶心，呕吐，腹部疼痛，吞咽困难和食物症状等症状，与食管嗜酸性粒细胞结合发生。迄今为止，在EOE中进行诊断和遵循治疗反应的唯一方法是活检的侵入性内窥镜检查。虽然内窥镜检查通常是安全的，但仍需要精确，侵入性较低，廉价，全面和耐用的测试来确定治疗功效。 为了满足这一需求，研究者建议使用现有技术的新应用，肠肠道上的？（用于检测肠道贾第鞭毛疾病的基于弦的测试），以测量食道炎症（此处称为食管弦测试或EST）。研究者指出，初步数据为EST捕获患有嗜酸性粒细胞性食管炎的患者的腔腔样品中的EST捕获食管炎症介质的能力提供了大量证明，这表明：（1）嗜酸性粒细胞衍生的颗粒核蛋白水平与食管菌丝菌丝菌群中的水平均与腔内的水平相吻合。由EST捕获的与粘膜炎症相关，以及（2）这些炎性炎症的腔内生物标志物与EOE疾病活性显着相关。根据调查员的说法 发现支持将EST用作新型的微创仪器来监测嗜酸性食管炎的治疗功效。拟议的第2阶段的具体目的是，在660名儿童和成人中进行的多中心研究是：（1）确定一个嗜酸性食管炎生物标志物面板，该小组将提高EST对监测疾病活动的敏感性和特异性，以及（）验证Estate Estancipity biomarkaker Panel的能力，以监测治疗性效率。研究人员指出，初步数据表明，在过夜（12小时）测试（12小时）测试中使用ES的EST在患有EOE的儿童和成年人中测量疾病活动（食管炎症），并且较短的时间段，目前在预定的内窥镜检查之前进行活检。在该项目中，调查人员建议将此时间范围缩短为1小时的测试，这是一个临床相关的时间点，据信促进在门诊诊所环境中使用潜在的影响。