Clinical trial NCT05199532: Eosinophilic Gastrointestinal Disorders Registry
Official title: Eosinophilic Gastrointestinal Disorders Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilic Esophagitis
Eosinophilic Gastroenteritis
Eosinophilic Colitis
Eosinophilic Gastrointestinal Disease
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects of this study include patients followed at Lurie Children's Hospital for evaluation or treatment of an EGID. Patients receiving care at Lurie Children's hospital include residents of the greater Chicago area, as well as patients throughout the Midwest seeking care at a tertiary referral center. Patients suspected of having EGID present with a wide variety of symptoms, ranging from classic symptoms of EoE including dysphagia and food impaction, to more general symptoms of abdominal pain, heartburn, vomiting, food refusal, failure to thrive, and diarrhea. Diagnostic criteria for EGIDs rely on clinical symptoms and the presence of eosinophil-predominant inflammation on biopsy.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who do not consent to participate

Primary outcomes:
measure: Clinical/Patient-Reported Measures
timeFrame: through study completion, an average of 6 months to 1 year
measure: Endoscopic measures
timeFrame: through study completion, an average of 6 months to 1 year
measure: Physical exam findings
timeFrame: through study completion, an average of 6 months to 1 year
measure: Histologic features
timeFrame: through study completion, an average of 6 months to 1 year
measure: Molecular measures
timeFrame: through study completion, an average of 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Joshua B Wechsler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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