NCT02328170

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

December 11, 2014

Last Update Submit

March 21, 2017

Conditions

Allergy

Keywords

immunoglobulin E, food hypersensitivities, child, allergens

Outcome Measures

Primary Outcomes (1)

  • specific IgE levels measured by EUROIMMUN Allergy and ImmunoCap

    14 months

Study Arms (2)

EUROIMMUN Allergy

Immunoblot assay

Other: EUROIMMUN Allergy

ImmunoCap

Fluoroallergosorbent test

Other: ImmunoCap

Interventions

EUROIMMUN AllergyOTHER

Immunoblot assay

EUROIMMUN Allergy
ImmunoCapOTHER

Fluoroallergosorbent test

ImmunoCap

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Clotted blood 3 mL

MeSH Terms

Conditions

HypersensitivityFood Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System DiseasesHypersensitivity, Immediate

Study Officials

  • Jittima Veskitkul, Assist Prof.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 31, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2016

Study Completion

February 1, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)