The Basophil Activation Test For Egg Allergy

NCT06559319 | Active Not Recruiting DMC

• 1 other identifier: 2024-117
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, basophil activation test (BAT) established by the investigators' lab was evaluated for its sensitivity and specificity in child egg allergy diagnosis. Children with suspected IgE mediated allergy to egg will be recruited in the study. Specific IgE to egg allergen and BAT will be detected. The diagnostic accuracy of the BAT will be assessed against clinical diagnosis based on history, clinical symptoms and laboratory results.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the BAT

  Sensitivity of the BAT compare to clinical comprehensive diagnosis with a threshold value of 5% for the BAT in a population of child egg allergy. Sensitivity is defined as the capacity for BAT to have a positive result when comprehensive diagnosis result is also positive

  2 days

• Specificity of the BAT

  Specificity is defined as the capacity for BAT to have a negative result when comprehensive diagnosis result is also negative.

  2 days

Interventions

blood sampling DIAGNOSTIC_TEST

Venous blood is collected, and sIgE and BAT will be detected using whole blood and serum, respectively.

Eligibility Criteria

• Age: 4 Months - 6 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with suspected egg allergy

You may not qualify if:

• Patients with hematological tumors, autoimmune diseases, organ transplantation, and immunodeficiency diseases
• Take immunosuppressants, immunomodulators, statins, and inject anesthetics within 3 weeks

Sponsors & Collaborators

• Xia Peng: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, China

Location

Related Publications (16)

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• Kim YH, Kim YS, Park Y, Kim SY, Kim KW, Kim HS, Sohn MH. Investigation of Basophil Activation Test for Diagnosing Milk and Egg Allergy in Younger Children. J Clin Med. 2020 Dec 5;9(12):3942. doi: 10.3390/jcm9123942.

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  PMID: 29247714 RESULT

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  PMID: 28342912 RESULT

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  PMID: 33300157 RESULT

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Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators need collect whole blood to perform BAT, and need serum to detect sIgE

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate senior technologist

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 10, 2024
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)