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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 : June 10, 2019
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

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

Condition or disease
Eosinophilic Esophagitis

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.


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : December 17, 2028
Estimated Study Completion Date : December 17, 2028

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Esophageal biopsies and/or cells derived from biopsies and Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980886


Contacts
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Contact: Emad Khosh hemmat, BS 8589661700 ext 226884 ekhoshhe@Ucsd.edu
Contact: Seema S Aceves, MD, PhD 8585342983 saceves@ucsd.edu

Locations
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United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Emad Khosh hemmat, BS    858-966-1700 ext 226884    ekhoshhe@ucsd.edu   
Contact: Seema Aceves, MD,PhD    8589665961    saceves@ucsd.edu   
Principal Investigator: Seema Aceves, MD.PhD         
Sub-Investigator: Ranjan Dohil, MD         
Sub-Investigator: Robert Newbury, MD         
Sub-Investigator: Cathleen Collins, MD         
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: Seema Aceves, Professor, Pediatrics and Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03980886     History of Changes
Other Study ID Numbers: 181690
1K24AI135034-01 ( U.S. NIH Grant/Contract )
5R01AI092135-07 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: May 2019
Individual Participant Data (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

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

Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases