Eosinophilic Esophagitis Databank (CoFAR5)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01323803
First received: March 24, 2011
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

Condition
Esophagitis
Eosinophilic Esophagitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
blood and saliva

Enrollment: 709
Study Start Date: April 2011
Estimated Study Completion Date: August 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Months to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with biopsy proven Eosinophilic Esophagitis
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323803

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01323803     History of Changes
Other Study ID Numbers: DAIT CoFAR5 
Study First Received: March 24, 2011
Last Updated: March 3, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Eosinophilic Esophagitis

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

ClinicalTrials.gov processed this record on August 23, 2016