Data and Sample Collection Study to Elucidate the Mechani... | NCT00267501

Studies
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders

NCT00267501

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Recruiting

Last Update Posted

Sep 17, 2025Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease
Food Allergy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01 DK075401

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Jan 2050Estimated

Completion Date

Jan 2050Estimated

First Submitted Date

Dec 15, 2005

First Submission Date that Met QC Criteria

Dec 19, 2005

First Posted Date

Dec 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with eosinophilic disorders and patients without eosinophilic disorders to serve as normal controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bliss Magella	Contact	513-636-7832		bliss.magella@cchmc.org

Overall Officials

Name	Affiliation	Role
Marc E. Rothenberg, M.D., Ph.D.	Cincinnati Children's Hospital Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center	Recruiting	Cincinnati	Ohio	45229-3039	United States

Condition Browse Module

MeSH Terms

ID	Term
D005512	Food Hypersensitivity
D004802	Eosinophilia

Ancestor Terms

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D007960	Leukocyte Disorders

Browse Leaves

Not provided

Browse Branches

Not provided