Eosinophilic Esophagitis Databank

Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01323803

Acronym

CoFAR5

Enrollment

709

Registered

2011-03-28

Start date

2011-04-30

Completion date

2016-02-29

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis, Esophagitis

Keywords

Eosinophilic Esophagitis

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Months to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis	48 months	A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from \>1.5 million genetic markers will be conducted.

Countries

United States

Outcome results