Clinical trial NCT03980886: Characteristics and Inflammatory Markers in Children with Eosinophilic Esophagitis (EoE)
Official title: Characteristics and Inflammatory Markers in Children with Eosinophilic Esophagitis (EoE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilic Esophagitis
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-06-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD

Brief summary: Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers

Detailed description: Participants with a diagnosis of EoE are recruited from Rady Children's Hospital Eosinophilic Gastrointestinal Disorders (EGID) during routine clinic and/or endoscopy visits.

Medical information including clinical symptoms, endoscopy, histopathology, medical and surgical history, lab and imaging findings, are entered into a UCSD database at each clinic or endoscopy visit. Blood and biopsy specimens are procured and utilized for analysis of inflammatory molecules and for isolation of structural cells. This protocol continues our clinical database and sample collection in children with EoE. The database provides a cohort of EoE patients for studies of natural history, therapeutic response, and disease progression. In a relatively new disease of increasing incidence, these studies will provide information on disease progression and the clinical characteristics of patients who have varying disease phenotypes as well as the associations between clinical phenotypes, molecular changes, and disease course. The procurement and storage of tissue, cells, and serum samples provides a repository for studies of EoE-related molecules and peripheral markers in clinically phenotyped patients. In addition, the study of these esophageal cells will provide an in vitro model system for assessing the molecular mechanisms of disease pathogenesis in EoE.

Eligibility criteria: Inclusion Criteria:

* Have a known EoE diagnosis
* Complain of dysphagia, vomiting, or abdominal pain, especially if recalcitrant to acid blocking therapy (but does not have to be recalcitrant to acid blocking medications)
* Present with food impaction
* Present with esophageal stricture
* Have characteristic endoscopic findings of EoE of pallor, linear furrows, lichenification, white plaques, or concentric rings

Exclusion Criteria:

* None

Primary outcomes:
measure: The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care
timeFrame: 10 years
measure: The longitudinal trajectory of inflammatory markers in blood and biopsies in pediatric EoE during routine clinical care
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
Study officials:
References: