Clinical trial Recruiting at 2 sites Observational Ages 6 Months to 99

Testing a new method for measuring allergy-related IgE levels

Official title: Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood

Run by University Hospital, Toulouse · NCT04751760 · Data updated 2026-11-12

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 typeObservational
Ages6 Months to 99 Years
SexAll
Enrollment1376 (estimated)
SponsorUniversity Hospital, Toulouse
Academic / other
Locations2 sites (Toulouse and 1 other locations)
StatusRecruiting
StartedApril 20, 2021
Main results expectedApril 20, 2026
Study endsApril 20, 2026
Registry record updatedMarch 19, 2026
Trial IDNCT04751760 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include males and females aged 6 months and older who have a confirmed allergy or sensitization to specific allergens.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University Hospital
    Toulouse, France
    Recruiting
  • Larrey hospital
    Toulouse, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.