Characteristics and Inflammatory Markers in Children with Eosinophilic Esophagitis (EoE)
EoE
3 other identifiers
observational
1,500
1 country
1
Brief Summary
Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2019
CompletedFirst Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 17, 2028
November 25, 2024
November 1, 2024
9.9 years
April 23, 2019
November 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Eligibility Criteria
The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
Biospecimen
Esophageal biopsies and/or cells derived from biopsies and Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Pediatrics and Medicine
Study Record Dates
First Submitted
April 23, 2019
First Posted
June 10, 2019
Study Start
February 11, 2019
Primary Completion (Estimated)
December 17, 2028
Study Completion (Estimated)
December 17, 2028
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Ongoing
De-identified information and samples might be shared with other researchers at other institutions