EsophagitisCoFAR5NCT01323803
Eosinophilic Esophagitis Databank
An observational study of Esophagitis and Eosinophilic Esophagitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Esophagitis, Eosinophilic Esophagitis
- How many people
- 709 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2011to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with biopsy proven Eosinophilic Esophagitis
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of North Carolina
Chapel Hill, North Carolina, 27599
National Jewish Health
Denver, Colorado, 80206
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)
This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.
Read the 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.
- Conditions
- Esophagitis, Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis
- Medical subject headings
- Esophagitis, Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis
A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from >1.5 million genetic markers will be conducted.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EsophagitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marc E. Rothenberg, M.D., Ph.D., Principal investigator, Children's Hospital Medical Center, CincinnatiMirna Chehade, MD, MPH, Principal investigator, Mt. Sinai School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323803
- Sponsor's protocol ID
- DAIT CoFAR5
- Acronym
- CoFAR5
- Status last verified
- Aug 2017
- First submitted
- 24 Mar 2011
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25017104
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)
- ClinicalTrials.gov ID
- NCT01323803
- Acronym / sponsor ID
- CoFAR5 / DAIT CoFAR5
- Conditions
- Esophagitis, Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with biopsy proven Eosinophilic Esophagitis
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis
Time frame: 48 months
A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from >1.5 million genetic markers will be conducted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Results publication: PubMed 25017104Kottyan 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Link provided by the sponsor.
Related trials for Esophagitis
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Natural History and Genetics of Food Allergy and Related Conditions
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SPADE Clinical Trial.
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Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc E. Rothenberg, M.D., Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
Mirna Chehade, MD, MPH principal investigator
Mt. Sinai School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagitis and Eosinophilic Esophagitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01323803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.