Eosinophilic Gastrointestinal Disorders Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical/Patient-Reported Measures
研究概览
简要总结
The purpose of this study is to learn more about Eosinophilic Gastrointestinal Disorders (EGIDs). With this registry we hope to find out more about the symptoms that patients have during their treatment, the quality of life they have with the diagnosis, what the disease looks like throughout the different treatment methods, and if there is a connection between EGIDs and connective tissue disorders.
The goal of this study is to be able to better understand EGIDs and use information gained from all the information collected on this study for more precise treatments in the future. We want to create a large collection of samples, called a biorepository, to learn the most about EGIDs as possible. When the samples are collected, which will occur at procedures directed by your child's doctor as part of their standard of care, they will be stored for an unlimited amount of time to perform experiments on these samples and to gather information about EGIDs
详细描述
Eosinophilic gastrointestinal disorders (EGIDs) comprise a family of disorders that includes Eosinophilic Esophagitis (EoE), Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC). The natural history of EGIDs is not well characterized. The aim of this registry is to create a comprehensive prospective database of EGID patients as a foundation towards an improved understanding of disease progression and pathophysiologic mechanism. There is a critical need to understand the relationship between disease mechanism, treatment response, measurements of disease severity, and noninvasive disease activity monitoring strategies. Characterization of the spectrum of clinical phenotype of EGIDs is important in the search for novel pathogenic molecules/pathways to inform targeted treatment strategies.
This study proposes to establish an EGID patient registry comprised of data collected from patients at Lurie Children's Hospital of Chicago undergoing standard of care evaluation, diagnosis, and treatment for EGIDs. The registry aims to characterize the clinical phenotype of EGIDs by examining (1) clinical, endoscopic, and histologic characteristics of EGID patients compared to non-EGID controls; (2) clinical, endoscopic, and histologic response of EGID patients to treatment; (3) functional assessment of the esophagus in patients undergoing evaluation for and with established diagnosis of EoE; (4) patient-reported quality of life and symptom scales; (5) the association of EGIDs with inherited Connective Tissue Disorders (CTDs) and dysautonomia, and (6) cellular and molecular biomarkers of disease severity. Our aim is to perform a prospective analysis of all EoE, EG, EGE, and EC patients, as well as patients suspected of having an EGID evaluated at Lurie Children's Hospital. Patients who are suspected of having an EGID and those with an established diagnosis of an EGID will be approached for recruitment into the registry.
The data and samples collected during this study are important to this study and to future research related to EGIDs. The data and samples will be used as indicated within this protocol and remaining samples and data will be stored and kept for future research studies on gastrointestinal diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 25 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an established diagnosis of an EGID, based on pathology findings from an endoscopy or colonoscopy with biopsies.
- •Patients suspected of having an EGID and undergoing endoscopic evaluation for further assessment
排除标准
- •Patients who do not consent to participate
结局指标
主要结局
Clinical/Patient-Reported Measures
时间窗: through study completion, an average of 6 months to 1 year
Families complete questionnaires regarding reported symptoms and quality of life as well as family history, patient history and dietary checklists. Change in responses will be assessed at collection timepoints
Endoscopic measures
时间窗: through study completion, an average of 6 months to 1 year
Endoscopy visual findings will be evaluated using EREFS measurements, which measure the visual findings of Exudates, Rings, Edema, Furrows, and Strictures
Physical exam findings
时间窗: through study completion, an average of 6 months to 1 year
hypermobility as assessed by Beighton Score, assessed from 5 questions on a 0-2 scale with a higher score reporting a positive association with hypermobility
Histologic features
时间窗: through study completion, an average of 6 months to 1 year
Histology markers of eosinophilic esophagitis, specifically eos/hpf, will be assessed at standard of care endoscopies to show change throughout study participation
Molecular measures
时间窗: through study completion, an average of 6 months to 1 year
In particular, we will assess mast cells and t-cells, and their mediators that are increased in EGIDs
次要结局
未报告次要终点
研究者
Joshua Wechsler
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago
