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

ConditionAllergy and Immunology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-99
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females 6 months' old or older

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

Disqualifiers

Children younger than 6 months'old

Children's weight less than 10 kg

Pregnant or breastfeeding women

Patients with cystic fibrosis

Trial population

patients followed at the Toulouse University Hospital and presenting sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • collection of blood and urine

    Biological/Vaccine

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

Treatment groups

1,376 Participants
are divided into 1 treatment group
Group A: People with sensitization or allergy1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0

Secondary outcomes

1

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

Time frame
Day 0
2

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

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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