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

NCT ID: NCT03980886

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-11

Study Completion Date

2028-12-17

Brief Summary

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

Detailed Description

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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.

Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Seema Aceves

Professor, Pediatrics and Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rady Children's Hospital San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kira Chaiboonma, BS

Role: CONTACT

8589661700 ext. 226884

Seema S Aceves, MD, PhD

Role: CONTACT

8585342983

Facility Contacts

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Kira Chaiboonma, BS

Role: primary

8589661700 ext. 226884

Seema Aceves, MD,PhD

Role: backup

8589665961

Seema Aceves, MD.PhD

Role: backup

Ranjan Dohil, MD

Role: backup

Jun Mo, MD

Role: backup

Cathleen Collins, MD

Role: backup

Other Identifiers

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2R56AI092135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R01DK114457

Identifier Type: NIH

Identifier Source: secondary_id

View Link

181690

Identifier Type: -

Identifier Source: org_study_id

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