Eosinophilic Gastrointestinal Disorders (EGID)EoENCT01382563
Registry for Eosinophilic Gastrointestinal Disorders (REGID)
An observational study of Eosinophilic Gastrointestinal Disorders (EGID) and Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 8 sites in United States.
Trial summary
Develop Registry tool Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Eosinophilic Gastrointestinal Disorders (EGID), Eosinophilic Esophagitis, Eosinophilic Disorder
- How many people
- 34 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2012to Dec 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Eosinophilic Gastrointestinal Disorders
Who may be able to join
- Eosinophilic Gastrointestinal Disorder diagnosis
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The Children's Hospital
Aurora, Colorado, 80045
University of North Carolina
Chapel Hill, North Carolina, 25799
Northwestern University School of Medicine
Chicago, Illinois, 60611-2951
Riley Children's Hospital
Indianapolis, Indiana, 46202
Kara Kliewer
Mason, Ohio, 45040
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rady Children's Hospital
San Diego, California, 92123-6791
About this study
Develop Registry tool
Read the detailed description
The purpose of this research study is to develop a registry tool used for the management and care of patients with eosinophilic disorders, and create a research resource that will provide further insights into these disorders.
- Conditions
- Eosinophilic Gastrointestinal Disorders (EGID), Eosinophilic Esophagitis, Eosinophilic Disorder
- Keywords
- Eosinophilic Gastrointestinal Disorders, EGID, Eosinophilic Esophagitis, Registry, Eosinophils, Eosinophilia, Eosinophilic enteropathy, Eosinophilic enteritis, Eosinophilic gastritis, Eosinophilic gastroenteritis, Eosinophilic gastroenteropathy
- Medical subject headings
- Eosinophilic Esophagitis, Eosinophilia, Eosinophilic enteropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Registry Aim
The registry will allow for the standardization of care while also allowing us to identify gaps in care that need to be addressed and areas for future research at Cincinnati Children's Hospital Medical Center (CCHMC) and collaborating sites around the nation.
Measured: Open-ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startNov 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Gastrointestinal Disorders (EGID)Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Other
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc E. Rothenberg, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382563
- Sponsor's protocol ID
- 2010-1579
- Acronym
- EoE
- Status last verified
- Aug 2020
- First submitted
- 24 Jun 2011
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Eosinophilic Gastrointestinal Disorders (REGID)
- ClinicalTrials.gov ID
- NCT01382563
- Acronym / sponsor ID
- EoE / 2010-1579
- Conditions
- Eosinophilic Gastrointestinal Disorders (EGID), Eosinophilic Esophagitis, Eosinophilic Disorder
- Keywords
- Eosinophilic Gastrointestinal Disorders, EGID, Eosinophilic Esophagitis, Registry, Eosinophils, Eosinophilia, Eosinophilic enteropathy, Eosinophilic enteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jun 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.
Develop Registry tool
Detailed description
The purpose of this research study is to develop a registry tool used for the management and care of patients with eosinophilic disorders, and create a research resource that will provide further insights into these disorders.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eosinophilic Gastrointestinal Disorders
Key inclusion criteria (1 listed)
- Eosinophilic Gastrointestinal Disorder diagnosis
Key exclusion criteria (0 listed)
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
Registry Aim
Time frame: Open-ended
The registry will allow for the standardization of care while also allowing us to identify gaps in care that need to be addressed and areas for future research at Cincinnati Children's Hospital Medical Center (CCHMC) and collaborating sites around the nation.
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 2 Sep 2020.
Related trials for Eosinophilic Gastrointestinal Disorders (EGID)
RecruitingObservational study
Elimination Diet Strategies and Histologic Remission in Children With Eosinophilic Gastrointestinal Disorders
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Active, not recruitingPhase 2
A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have
Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD)
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, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Gastrointestinal Disorders (EGID) and Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 8 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 1 inclusion and 0 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Registry Aim (time frame: Open-ended). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.