Testing a new method for measuring allergy-related IgE levels
Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood
This study is testing a new way to measure allergy-related IgE levels using less blood and faster results to help both kids and adults with allergies get diagnosed and treated more easily.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1376 (estimated) |
| Ages | 6 Months to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 2 sites (Toulouse and 1 other locations) |
| Trial ID | NCT04751760 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a new specific IgE assay called LuLISA, which utilizes a bioluminescence technique to analyze blood and urine samples from both pediatric and adult patients with allergies. The current standard method, ImmunoCAP, is costly and requires a significant amount of blood, which poses challenges especially for children. By using the LuLISA method, the study seeks to reduce the amount of blood needed and improve the turnaround time for results, potentially allowing for quicker diagnosis and management of allergies. The study will involve collecting samples during routine follow-up visits for allergy patients.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 6 months and older who have a confirmed allergy or sensitization to specific allergens.
Not a fit: Patients younger than 6 months, those weighing less than 10 kg, pregnant or breastfeeding women, and individuals with certain autoimmune conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this new assay could provide a more efficient and less invasive way to diagnose allergies, leading to better patient management.
How similar studies have performed: While the LuLISA method has shown promise for quantifying IgE against specific allergens, its broader application for other allergens is still being explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse and 1 other locations
- University Hospital — Toulouse, France (Recruiting)
- Larrey hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Marine Michelet, MD — University Hospital, Toulouse
- Study coordinator: Marine Michelet, MD
- Email: michelet.m@chu-toulouse.fr
- Phone: 33-5 34 55 85 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.