Feasibility Study of a New Immunoglobulin E (IgE) Assay Method
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collection of blood and urine.
- Who it may be relevant to
- Registry conditions: Allergy and Immunology. Basic parameters: 6 months — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood
Overview
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
- Biological 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
- Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods [Time frame: Day 0]
Secondary outcome measures (2)
- To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA [Time frame: Day 0]
- To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood [Time frame: Day 0]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 2 centers
- University Hospital — Toulouse
- Larrey hospital — Toulouse
Identifiers
NCT: NCT04751760 · RC31/20/0293