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NCT Number: NCT04751760

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

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.

Recruiting

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Key information

Age range

6 month–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Larrey hospital, Toulouse, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collection of blood and urine

Biological

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

Primary outcomes

  1. Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods

    Time frame: Day 0

    specific IgE concentrations for a given allergen will be measured by both LuLISA and ImmunoCAP and the results will be compared

Secondary outcomes

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

    Time frame: Day 0

    specific IgE concentrations for a given allergen will be measured in the sera and the urine from the same patient and the results will be compared

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

    Time frame: Day 0

    specific IgE concentrations for a given allergen will be measured in the venous blood and the capillary blood from the same patient and the results will be compared

Study contacts

Contact information is provided by the study sponsor or research team.

Marine Michelet, MD

CONTACT

[email protected]

33-5 34 55 85 85

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: LuLISA

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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