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

Allergy and Immunology Clinical Trial

— LuLISA  

Official title:

Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751760
• Other study ID #: RC31/20/0293
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: January 7, 2026

Study information

• Verified date: March 2024
• Source: University Hospital, Toulouse
• Contact: Marine Michelet, MD
• Phone: 33-5 34 55 85 85
• Email: michelet.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1376
• Est. completion date: January 7, 2026
• Est. primary completion date: January 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy and Immunology
• Hypersensitivity

Intervention

Biological:
• collection of blood and urine
blood and urine will be collected during a blood test scheduled for the follow-up of the patient

Locations

Country	Name	City	State
France	Larrey hospital	Toulouse
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods	specific IgE concentrations for a given allergen will be measured by both LuLISA and ImmunoCAP and the results will be compared	Day 0
Secondary	To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA	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	Day 0
Secondary	To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood	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	Day 0