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

NCT04751760 | Recruiting

• 1 other identifier: RC31/20/0293
• Study Type: observational
• Target: 1,376
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergy and Immunology

Keywords

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

Outcome Measures

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

  Day 0

Secondary Outcomes (2)

• To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA

  Day 0

• To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood

  Day 0

Study Arms (1)

People with sensitization or allergy

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

Biological: collection of blood and urine

Interventions

collection of blood and urine BIOLOGICAL

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

People with sensitization or allergy

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

University Hospital

Toulouse, 31000, France

RECRUITING

Larrey hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Interventions

Urination

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Marine Michelet, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine Michelet, MD

CONTACT

33-5 34 55 85 85; michelet.m@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: April 20, 2021
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)