French University Hospital conducts a Feasibility Study of a New Immunoglobulin E (IgE) Assay Method
The University Hospital, Toulouse is commencing recruitment for the clinical trial of the Feasibility Study of a New Immunoglobulin E (IgE) Assay Method.
The condition is Allergy and Immunology.
A new clinical trial is recruiting patients in the following locations: France.
The trial officially began on the January 8, 2021 and is planned to complete on January 7, 2024.
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.
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 (Goyard et al. Allergy 2020) 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. This study also plan to determine the IgE repertoire of B lymphocytes of allergic adults by taking advantage of the high sensitivity of the LuLISA technique to quantify allergen-specific IgE at the single cell level. This is a new technique that aims to identify key IgE clones involved in allergic reactions.
The population that are excluded from participation:
- 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
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04751760
