跳至主要内容
临床试验/NCT01323803
NCT01323803已完成不适用

Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)

National Institute of Allergy and Infectious Diseases (NIAID)5 个研究点 分布在 1 个国家目标入组 709 人开始时间: 2011年4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
709
试验地点
5
主要终点
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis

研究概览

简要总结

This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

详细描述

Eosinophilic esophagitis (EoE) is a newly recognized chronic disease that is increasingly being diagnosed in children and adults. Many patients with EoE also have food allergies. EoE is characterized by inflammation and accumulation of a specific type of immune cell, called an eosinophil, in the esophagus. While there have been several large studies of EoE, very few have focused on the roles the immune system, genetics/heredity, and the environment in EoE.

The samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis.

The Cincinnati Children's Hospital Medical Center will serve as the Central Laboratory for genetic characterization studies.

研究设计

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

入排标准

年龄范围
6 Months 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing;
  • Documented diagnosis of EoE at any time confirmed by study team (pathology report describing greater than or equal to 15 eosinophils/hpf in peak field of an esophageal biopsy. Participants with eosinophilia in extra-esophageal tissue are permitted).

排除标准

  • Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites;
  • Participants with a history of persistent eosinophilia greater than 1500 cells/mcl of blood.

结局指标

主要结局

Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis

时间窗: 48 months

A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from \>1.5 million genetic markers will be conducted.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (5)

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