Eosinophilic Gastrointestinal Disorders Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis, Eosinophilic Gastroenteritis, Eosinophilic Colitis, Eosinophilic Gastrointestinal Disease. Basic parameters: 1 year — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Clinical/Patient-Reported Measures [Time frame: through study completion, an average of 6 months to 1 year]
- Endoscopic measures [Time frame: through study completion, an average of 6 months to 1 year]
- Physical exam findings [Time frame: through study completion, an average of 6 months to 1 year]
- Histologic features [Time frame: through study completion, an average of 6 months to 1 year]
- Molecular measures [Time frame: through study completion, an average of 6 months to 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ann & Robert H Lurie Children's Hospital of Chicago — Chicago
Publications
- Dellon ES, Hirano I. Epidemiology and Natural History of Eosinophilic Esophagitis. Gastroenterology. 2018 Jan;154(2):319-332.e3. doi: 10.1053/j.gastro.2017.06.067. Epub 2017 Aug 1. PMID 28774845
- O'Shea KM, Aceves SS, Dellon ES, Gupta SK, Spergel JM, Furuta GT, Rothenberg ME. Pathophysiology of Eosinophilic Esophagitis. Gastroenterology. 2018 Jan;154(2):333-345. doi: 10.1053/j.gastro.2017.06.065. Epub 2017 Jul 27. PMID 28757265
- Jensen ET, Kappelman MD, Martin CF, Dellon ES. Health-care utilization, costs, and the burden of disease related to eosinophilic esophagitis in the United States. Am J Gastroenterol. 2015 May;110(5):626-32. doi: 10.1038/ajg.2014.316. Epub 2014 Sep 30. PMID 25267327
- Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863. PMID 26488694
- Steinbach EC, Hernandez M, Dellon ES. Eosinophilic Esophagitis and the Eosinophilic Gastrointestinal Diseases: Approach to Diagnosis and Management. J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1483-1495. doi: 10.1016/j.jaip.2018.06.012. Epub 2018 Jul 3. PMID 30201096
- Dellon ES, Liacouras CA, Molina-Infante J, Furuta GT, Spergel JM, Zevit N, Spechler SJ, Attwood SE, Straumann A, Aceves SS, Alexander JA, Atkins D, Arva NC, Blanchard C, Bonis PA, Book WM, Capocelli KE, Chehade M, Cheng E, Collins MH, Davis CM, Dias JA, Di Lorenzo C, Dohil R, Dupont C, Falk GW, Ferreira CT, Fox A, Gonsalves NP, Gupta SK, Katzka DA, Kinoshita Y, Menard-Katcher C, Kodroff E, Metz DC PMID 30009819
- Godwin B, Wilkins B, Muir AB. EoE disease monitoring: Where we are and where we are going. Ann Allergy Asthma Immunol. 2020 Mar;124(3):240-247. doi: 10.1016/j.anai.2019.12.004. Epub 2019 Dec 9. PMID 31830586
- Carlson DA, Lin Z, Hirano I, Gonsalves N, Zalewski A, Pandolfino JE. Evaluation of esophageal distensibility in eosinophilic esophagitis: an update and comparison of functional lumen imaging probe analytic methods. Neurogastroenterol Motil. 2016 Dec;28(12):1844-1853. doi: 10.1111/nmo.12888. Epub 2016 Jun 16. PMID 27311807
Identifiers
NCT: NCT05199532 · 2020-3601