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

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ClinicalTrials.gov Identifier: NCT03980886
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : March 4, 2021
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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