Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE) (EoE)

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

Study Overview

• Status: Recruiting
• Conditions: Eosinophilic Esophagitis

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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Kira Chaiboonma, BS; Phone Number: 226884 8589661700; Email: kchaiboonma@health.ucsd.edu
• Study Contact Backup: Name: Seema S Aceves, MD, PhD; Phone Number: 8585342983; Email: saceves@ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital San Diego
      • Contact: Kira Chaiboonma, BS; Phone Number: 226884 858-966-1700; Email: kchaiboonma@health.ucsd.edu
      • Contact: Seema Aceves, MD,PhD; Phone Number: 8589665961; Email: saceves@ucsd.edu
      • Principal Investigator: Seema Aceves, MD.PhD
      • Sub-Investigator: Ranjan Dohil, MD
      • Sub-Investigator: Jun Mo, MD
      • Sub-Investigator: Cathleen Collins, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care	Outcome measures of symptoms, histology, endoscopy, and lab values such as peripheral eosinophilia and cortisol procured at each clinical and/or endoscopy visit will be entered and tracked in a UCSD/RCHSD de-identified database in order to understand their longitudinal trajectory during routine clinical care	10 years
The longitudinal trajectory of inflammatory markers in blood and biopsies in pediatric EoE during routine clinical care	The presence and severity of inflammatory markers and cells over time in specimens collected during routine endoscopy and biopsy will be measured to understand their alignment with outcome measures of symptoms, histology, and endoscopy	10 years

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Anticipated): December 17, 2028
• Study Completion (Anticipated): December 17, 2028

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: 181690; 1K24AI135034-01 (U.S. NIH Grant/Contract); 5R01AI092135-07 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified information and samples might be shared with other researchers at other institutions
• IPD Sharing Time Frame: Ongoing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No