Clinical trial NCT04751760: Feasibility Study of a New Immunoglobulin E (IgE) Assay Method
Official title: Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy and Immunology
Keywords: IgE assay
food allergy/ hypersensitivity
respiratory allergy/ hypersensitivity
hymenopter allergy/ hypersensitivity
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 1376
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients followed at the Toulouse University Hospital and presenting sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods
timeFrame: Day 0
Secondary outcomes:
measure: To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA
timeFrame: Day 0
measure: To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood
timeFrame: Day 0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
city: Toulouse
country: France
facility: Larrey hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Marine Michelet, MD
role: PRINCIPAL_INVESTIGATOR
References: