Eosinophilic Esophagitis Databank

NCT ID: NCT01323803

Last Updated: 2017-08-28

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

COMPLETED

Total Enrollment

709 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-02-29

Brief Summary

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This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

Detailed Description

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Eosinophilic esophagitis (EoE) is a newly recognized chronic disease that is increasingly being diagnosed in children and adults. Many patients with EoE also have food allergies. EoE is characterized by inflammation and accumulation of a specific type of immune cell, called an eosinophil, in the esophagus. While there have been several large studies of EoE, very few have focused on the roles the immune system, genetics/heredity, and the environment in EoE.

The samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis.

The Cincinnati Children's Hospital Medical Center will serve as the Central Laboratory for genetic characterization studies.

Conditions

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Esophagitis Eosinophilic Esophagitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing;
* Documented diagnosis of EoE at any time confirmed by study team (pathology report describing greater than or equal to 15 eosinophils/hpf in peak field of an esophageal biopsy. Participants with eosinophilia in extra-esophageal tissue are permitted).

Exclusion Criteria

* Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites;
* Participants with a history of persistent eosinophilia greater than 1500 cells/mcl of blood.
Minimum Eligible Age

6 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc E. Rothenberg, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Mirna Chehade, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai School of Medicine

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Kottyan LC, Davis BP, Sherrill JD, Liu K, Rochman M, Kaufman K, Weirauch MT, Vaughn S, Lazaro S, Rupert AM, Kohram M, Stucke EM, Kemme KA, Magnusen A, He H, Dexheimer P, Chehade M, Wood RA, Pesek RD, Vickery BP, Fleischer DM, Lindbad R, Sampson HA, Mukkada VA, Putnam PE, Abonia JP, Martin LJ, Harley JB, Rothenberg ME. Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet. 2014 Aug;46(8):895-900. doi: 10.1038/ng.3033. Epub 2014 Jul 13.

Reference Type RESULT
PMID: 25017104 (View on PubMed)

Related Links

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https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niddk.nih.gov/

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Other Identifiers

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DAIT CoFAR5

Identifier Type: -

Identifier Source: org_study_id

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