NCT00267475

Brief Summary

The purpose of this study is to conduct a translational study in patients with primary eosinophil associated gastrointestinal disorders \[EGID\] (e.g. eosinophilic esophagitis eosinophilic gastritis, eosinophilic enteritis \[EE\], eosinophilic colitis, and eosinophilic gastroenteritis \[EGE\]) with the aim of developing a data bank containing pertinent patient demographic information, tissue samples, and DNA, which will facilitate research on the pathophysiology of inflammatory disorders and the development of a verified successful clinical treatment program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 19, 2013

Status Verified

January 1, 2013

Enrollment Period

11.6 years

First QC Date

December 15, 2005

Last Update Submit

September 17, 2013

Conditions

Eosinophilic EsophagitisGastritisEnteritisEosinophilic ColitisEosinophilic Gastroenteritis

Keywords

eosinophilic esophagitiseosinophilic gastritiseosinophilic enteritiseosinophilic colitiseosinophilic gastroenteritis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with an eosinophilic disorder and patients without an eosinophilic disorder to serve as normal controls

Patients with an eosinophil associated gastrointestinal disorder (EGID), family members of patients with EGID, or normal controls.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Eosinophilic EsophagitisGastritisEnteritisEosinophilic enteropathy

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesStomach DiseasesIntestinal Diseases

Study Officials

  • Marc E. Rothenberg, M.D., Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 21, 2005

Study Start

May 1, 2001

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 19, 2013

Record last verified: 2013-01

Locations

US(1)