NCT01382563

Brief Summary

Develop Registry tool

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

4.1 years

First QC Date

June 24, 2011

Last Update Submit

August 31, 2020

Conditions

Eosinophilic Gastrointestinal Disorders (EGID)Eosinophilic EsophagitisEosinophilic Disorder

Keywords

Eosinophilic Gastrointestinal DisordersEGIDEosinophilic EsophagitisRegistryEosinophilsEosinophiliaEosinophilic enteropathyEosinophilic enteritisEosinophilic gastritisEosinophilic gastroenteritisEosinophilic gastroenteropathy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Open-ended

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Eosinophilic Gastrointestinal Disorders

You may qualify if:

  • Eosinophilic Gastrointestinal Disorder diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Rady Children's Hospital

San Diego, California, 92123-6791, United States

Location

The Children's Hospital

Aurora, Colorado, 80045, United States

Location

Northwestern University School of Medicine

Chicago, Illinois, 60611-2951, United States

Location

Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 25799, United States

Location

Kara Kliewer

Mason, Ohio, 45040, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

Eosinophilic EsophagitisEosinophiliaEosinophilic enteropathy

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Marc E. Rothenberg, MD, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 27, 2011

Study Start

November 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

US(8)