Feasibility Study of a New Immunoglobulin E (IgE) Assay Method

Recruiting

• Conditions: Allergy and Immunology
• Interventions: Biological: collection of blood and urine

• Registration Number: NCT04751760
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.

Detailed Description

Allergy is a raising public health problem. Specific IgE assays are useful tools to investigate the physiopathology of allergies. This method is achieved mainly by the ImmunoCAP enzyme immunoassay technique. This is an expensive test that requires a significant amount of blood. This is a limitation particularly in children. The time to get the results is long and a second consultation has to be scheduled in order to communicate the results to the patients. The main objective of this study is to assess the feasibility of a new specific IgE assay, named LuLISA, using a bioluminescence technique in urine and blood samples from pediatric and adult allergic population. This technique was recently published for the quantification of IgE against two peanut allergens and needs to be extended for the detection of other major allergens. A secondary objective is the evaluation of the time needed to obtain results.

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-12
• Study Start: 2021-04-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-01-07
• Study Completion: 2026-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1376

Inclusion Criteria

• Males or females 6 months' old or older

• Sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug proven by:

  • positive skin test (s)
  • and / or IgE specific (s)> 0.1 kUA / L
  • and / or anamnesis in favor of an allergic reaction of mediated IgE

• Social coverage up to date

Exclusion Criteria

• Children younger than 6 months'old
• Children's weight less than 10 kg
• Pregnant or breastfeeding women
• Patients with cystic fibrosis
• Patients with dysimmune or autoimmune pathology
• Anamnesis in favor of a delayed allergy or a contact allergy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with sensitization or allergy	collection of blood and urine	blood and urine will be collected during a blood test scheduled for the follow-up of the patient

Primary Outcome Measures

Name	Time	Method
Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods	Day 0	specific IgE concentrations for a given allergen will be measured by both LuLISA and ImmunoCAP and the results will be compared

Secondary Outcome Measures

Name	Time	Method
To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood	Day 0	specific IgE concentrations for a given allergen will be measured in the venous blood and the capillary blood from the same patient and the results will be compared
To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA	Day 0	specific IgE concentrations for a given allergen will be measured in the sera and the urine from the same patient and the results will be compared

Trial Locations

Locations (2)

University Hospital; 🇫🇷 Toulouse, France

Larrey hospital; 🇫🇷 Toulouse, France