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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04751760
Acronym
LuLISA
Enrollment
1376
Registered
2021-02-12
Start date
2021-04-20
Completion date
2026-04-20
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy and Immunology

Keywords

IgE assay, food allergy/ hypersensitivity, respiratory allergy/ hypersensitivity, hymenopter allergy/ hypersensitivity

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.

Interventions

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methodsDay 0specific IgE concentrations for a given allergen will be measured by both LuLISA and ImmunoCAP and the results will be compared

Secondary

MeasureTime frameDescription
To study the correlation between the results of specific serum and urinary IgE dosages by LuLISADay 0specific 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
To study the correlation between the results of specific IgE dosages in the venous blood and the capillary bloodDay 0specific 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

Countries

France

Contacts

CONTACTMarine Michelet, MD
michelet.m@chu-toulouse.fr33-5 34 55 85 85
PRINCIPAL_INVESTIGATORMarine Michelet, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026