跳至主要内容
临床试验/NCT03382678
NCT03382678已完成不适用

CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2018年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
187
试验地点
1
主要终点
Validation of EGID diagnosis

研究概览

简要总结

The purpose of this study is to validate the online cohort of EGID patients enrolled in the RDCRN CEGIR CR. In order to achieve this objective, the investigators will determine the agreement between self-reported EGID information by the enrollees and their physician's report and medical records. All participants enrolled in the RDCRN CEGIR CR with EGIDs will be invited via email to participate in this study.

详细描述

All individuals with EGID and enrolled in the RDCRN CEGIR CR will be invited to participate in this survey. As of 04/28, 1567 EGID patients have enrolled in CEGIR CR [EoE=1,217, EG=56, EGE=65, EC=52; multiple diseases=177]

The survey will be conducted through a pre-designed questionnaire. The questionnaire will be sent to participants via an introductory email wherein subjects will be informed about the purpose of this study. The questionnaire will gather self-reported clinical information (such as diagnosis, endoscopic procedures, histological findings in mucosal biopsies, and therapeutic plan). Consent will be obtained from participants to contact their physicians and allow their physicians to share relevant clinical information from their medical records.

Physicians identified by participants will be emailed a website link which will take them to a questionnaire. This questionnaire is designed to gather relevant information as documented in the patient's clinical records. Physicians will be able to submit the information online. It is anticipated that responding to this questionnaire would take less than 10 minutes of their time.

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
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in the RDCRN CEGIR Contact Registry, and with Internet access.
  • Diagnosis of EGID (EoE, EG, EGE, EE and/or EC)
  • Age: all ages. Parents/guardian of children < 18 years of age will respond to the questionnaire on behalf of their child.

排除标准

  • Inability to provide informed consent and complete survey
  • Unaffected family members of EGID patients
  • European Union participants who did not complete General Data Protection Regulation requirements.

结局指标

主要结局

Validation of EGID diagnosis

时间窗: 10 months

Assess the validity of self-reported EGID diagnosis by comparing to physician reports.

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 (1)

Loading locations...

相似试验

CEGIR 7807: Validation of Online Cohort of EGID... | 临床试验