- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01779154
Eosinophilic Gastrointestinal Disorders Patient Registry
June 16, 2016 updated by: Arkansas Children's Hospital Research Institute
The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that does not involve medical interventions, but serves as a record of demographics, characteristics of disease and treatment, utilization patterns, quality improvement measures and clinical outcomes.
The database is proposed so that epidemiologic research can be performed and current and accurate data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life.
Study Overview
Status
Withdrawn
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 21 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals with a diagnosis of an eosinophilic gastrointestinal disorder
Description
Inclusion Criteria:
- male or female participants of any race or ethnicity
- age 0 to 21 years
- diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis
Exclusion Criteria:
- hypereosinophilic syndrome
- non-eosinophilic gastrointestinal or allergic disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
eosinophilic gastrointestinal disorders
Individuals with a diagnosis of EGID including: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To define characteristics of an eosinophilic gastrointestinal disorder population in a rural southern state
Time Frame: After 12 months of data collection
|
To develop a database of patients with eosinophilic gastrointestinal disorders so that epidemiologic research can be performed and current data can be obtained regarding practice patterns, age and gender distributions, efficacy of treatment, clinical outcomes and changes in quality of life.
|
After 12 months of data collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robbie D Pesek, MD, University of Arkansas for Medical Sciences / Arkansas Children's Hospital Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ANTICIPATED)
May 1, 2017
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (ESTIMATE)
January 30, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
June 20, 2016
Last Update Submitted That Met QC Criteria
June 16, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Stomach Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Hypersensitivity
- Esophageal Diseases
- Leukocyte Disorders
- Eosinophilia
- Gastritis
- Gastrointestinal Diseases
- Digestive System Diseases
- Eosinophilic Esophagitis
- Enteritis
- Colitis
- Esophagitis
Other Study ID Numbers
- 136132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eosinophilic Gastritis
-
Children's Hospital Medical Center, CincinnatiAstraZenecaCompletedEosinophilic Gastritis or GastroenteritisUnited States
-
Allakos Inc.CompletedEosinophilic Gastritis | Eosinophilic DuodenitisUnited States
-
Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsCompletedEosinophilic Gastritis | Eosinophilic Gastroenteritis | Eosinophilic Esophagitis | Eosinophilic ColitisUnited States
-
Allakos Inc.CompletedEosinophilic Gastritis | Eosinophilic Gastroenteritis | Eosinophilic DuodenitisUnited States
-
Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsRecruitingEosinophilic Gastritis | Eosinophilic Gastroenteritis | Eosinophilic Esophagitis | Eosinophilic Colitis | Eosinophilic Gastrointestinal Disorders (EGIDs)United States
-
IRCCS Policlinico S. MatteoItalian Society of Pediatric Allergy & Immunology - Pediatric CentersRecruitingEosinophilic Esophagitis | Eosinophilic Colitis | Eosinophilic Gastritis or Gastroenteritis | Eosinophilic Gastrointestinal DisordersItaly
-
AstraZenecaCompletedEosinophilic Gastritis | Eosinophilic GastroenteritisItaly, Spain, United States, Vietnam, Japan, Netherlands, Ukraine, Poland, Brazil
-
Allakos Inc.CompletedEosinophilic Gastritis | Eosinophilic GastroenteritisUnited States
-
Children's Hospital Medical Center, CincinnatiNational Institutes of Health (NIH); Regeneron PharmaceuticalsActive, not recruitingEosinophilic Gastritis | Eosinophilic GastroenteritisUnited States
-
Regeneron PharmaceuticalsSanofiRecruitingEosinophilic Gastritis | Eosinophilic Duodenitis | Eosinophilic Gastrointestinal DiseaseUnited States, Poland, Italy, Japan, Australia