Eosinophilic Esophagitis Databank

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01323803
First received: March 24, 2011
Last updated: April 11, 2014
Last verified: April 2014

March 24, 2011
April 11, 2014
April 2011
April 2015   (final data collection date for primary outcome measure)
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01323803 on ClinicalTrials.gov Archive Site
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Eosinophilic Esophagitis Databank
Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)

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

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

blood and saliva

Probability Sample

Participants with biopsy proven Eosinophilic Esophagitis

  • Esophagitis
  • Eosinophilic Esophagitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
April 2015
April 2015   (final data collection date for primary outcome measure)

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 history of persistent eosinophilia greater than 1500 cells/mcl of blood
Both
6 Months to 65 Years
No
United States
 
NCT01323803
DAIT CoFAR5
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
Principal Investigator: Mirna Chehade, MD, MPH Mt. Sinai School of Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP