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临床试验/NCT02897271
NCT02897271已完成不适用

Demographics, Clinical Characteristics, and Pathology of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort

Children's Hospital Medical Center, Cincinnati6 个研究点 分布在 1 个国家目标入组 381 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
381
试验地点
6
主要终点
Mucosal eosinophilia (eos/hpf)

研究概览

简要总结

The purpose of this study is to investigate features of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).

详细描述

This retrospective chart review study will analyze the demographics, medical history, clinical features, and pathological data of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of an EGID including EG, EGE, and/or EC. Subjects with EoE can be included if they also have another EGID.
  • Clinical symptoms of gastrointestinal dysfunction.
  • Findings of increased eosinophils on tissue biopsy at the time of diagnosis, before treatment initiated.
  • Exclusion of other causes of gastrointestinal eosinophilia.

排除标准

  • Gastrointestinal eosinophilia caused by another disorder.
  • Diagnosis of EoE without another EGID.
  • Insufficient medical record or pathology data available to support an EGID diagnosis.

结局指标

主要结局

Mucosal eosinophilia (eos/hpf)

时间窗: Duration of funding, approximately 5 years

Mucosal eosinophil levels are measured as eosinophils per high power field (eos/hpf). The primary outcome measure is to determine the change in mucosal eosinophil level (eos/hpf) and to determine if the change in mucosal eosinophil level in eos/hpf correlates with other measures of disease activity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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