Comparative Study of Specific IgE Levels to Common Foods... | NCT02328170

Studies
Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Measured by EUROIMMUN Allergy and ImmunoCap

NCT02328170

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

235Actual

Phase

Not provided

Conditions

Allergy

Interventions

EUROIMMUN Allergy
ImmunoCap

Countries

Thailand

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

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Feb 2017Actual

First Submitted Date

Dec 11, 2014

First Submission Date that Met QC Criteria

Dec 26, 2014

First Posted Date

Dec 31, 2014Estimated

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

Mar 21, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the correlation of specific IgE levels to common foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap

Detailed Description

Children aged 0-15 years old who was diagnosed as asthma and/or allergic rhinitis, atopic dermatitis, food allergy, and underwent to measured specific IgE levels to suspicious relevant allergen, were invited to join the study.

Specific IgE levels of each patient was measured by EUROIMMUN Allergy and ImmunoCap.

The levels of specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, American cockroach, Bermuda, Johnson, Cat dander, Cow's milk, Egg white and wheat were determined the correlation between these two methods.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

235Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUROIMMUN Allergy		Immunoblot assay	Other: EUROIMMUN Allergy
ImmunoCap		Fluoroallergosorbent test	Other: ImmunoCap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUROIMMUN Allergy	Other	Immunoblot assay	EUROIMMUN Allergy
ImmunoCap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
specific IgE levels measured by EUROIMMUN Allergy and ImmunoCap		14 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosed as asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy and have to measured specific IgE levels to relevant allergens

Exclusion Criteria:

Having underlying disease including cardiovascular disease, chronic lung disease and immunodeficiency disease
Denied to enrolled to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

Patients who was diagnosed as having asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy, were enrolled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jittima Veskitkul, Assist Prof.	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok	Bangkok	10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D005512	Food Hypersensitivity

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided