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

• ClinicalTrials.gov Identifier: NCT03980886
• Recruitment Status: Recruiting
• First Posted: June 10, 2019
• Last Update Posted: March 4, 2021
• Sponsor: University of California, San Diego
• Collaborators: National Institutes of Health (NIH); National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Seema Aceves, University of California, San Diego

Tracking Information

• First Submitted Date: April 23, 2019
• First Posted Date: June 10, 2019
• Last Update Posted Date: March 4, 2021
• Actual Study Start Date: February 11, 2019
• Estimated Primary Completion Date: December 17, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 7, 2019)

• 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
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)
• Official Title: Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Esophageal biopsies and/or cells derived from biopsies and Blood

• Sampling Method: Non-Probability Sample
• Study Population: The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD
• Condition: Eosinophilic Esophagitis
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 7, 2019): 1200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 17, 2028
• Estimated Primary Completion Date: December 17, 2028 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kira Chaiboonma, BS; 8589661700 ext 226884; kchaiboonma@health.ucsd.edu

Contact: Seema S Aceves, MD, PhD; 8585342983; saceves@ucsd.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03980886
• Other Study ID Numbers: 181690; 1K24AI135034-01 ( U.S. NIH Grant/Contract ); 5R01AI092135-07 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified information and samples might be shared with other researchers at other institutions
• Time Frame: Ongoing

• Responsible Party: Seema Aceves, University of California, San Diego
• Study Sponsor: University of California, San Diego

Collaborators

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

• Investigators: Not Provided
• PRS Account: University of California, San Diego
• Verification Date: March 2021