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NCT Number: NCT03980886

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

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

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Key information

Age range

1 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location status: Recruiting

Location contact

Angie Rodriguez Verdin, BS

CONTACT

[email protected]

8589661700 ext. 225005

Cathleen Collins, MD

SUB_INVESTIGATOR

Jun Mo, MD

SUB_INVESTIGATOR

Ranjan Dohil, MD

SUB_INVESTIGATOR

Seema Aceves, MD,PhD

CONTACT

[email protected]

8589665961

Seema Aceves, MD.PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care

    Time frame: 10 years

    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

  2. The longitudinal trajectory of inflammatory markers in blood and biopsies in pediatric EoE during routine clinical care

    Time frame: 10 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Angie Rodriguez Verdin, BS

CONTACT

[email protected]

8589661700 ext. 225005

Seema S Aceves, MD, PhD

CONTACT

[email protected]

8585342983

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)

Registry information

Acronym: EoE

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2019
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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