Allergy and ImmunologyLuLISANCT04751760
Feasibility Study of a New Immunoglobulin E (IgE) Assay Method
An observational study of Allergy and Immunology, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 99 years
- Conditions the study is for
- Allergy and Immunology
- What is being tested?
- collection of blood and urine
- How many people
- 1,376 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Apr 2021to 20 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients followed at the Toulouse University Hospital and presenting sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
University Hospital
Toulouse, 31000
Marine Michelet, MD, 5 34 55 85 86 ext. 0033, michelet.m@chu-toulouse.fr
Françoise Auriol, PhD, 561779103 ext. 0033, auriol.f@chu-toulouse.fr
- Recruiting
Larrey hospital
Toulouse, 31059
Laurent Guilleminault, MD, 567771624 ext. 0033, guilleminault.l@chu-toulouse.fr
About this study
Official title: Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood
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.
Read the detailed description
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.
- Conditions
- Allergy and Immunology
- Being tested
- collection of blood and urine
- Keywords
- IgE assay, food allergy/ hypersensitivity, respiratory allergy/ hypersensitivity, hymenopter allergy/ hypersensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of blood and urineBiological
blood and urine will be collected during a blood test scheduled for the follow-up of the patient
| Study group | Role | What they receive |
|---|---|---|
| People with sensitization or allergy | blood and urine will be collected during a blood test scheduled for the follow-up of the patient Receives: Biological: collection of blood and urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (2)
To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA
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
Measured: Day 0
To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start20 Apr 2021
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy and ImmunologyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine Michelet, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751760
- Sponsor's protocol ID
- RC31/20/0293
- Acronym
- LuLISA
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood
- ClinicalTrials.gov ID
- NCT04751760
- Acronym / sponsor ID
- LuLISA / RC31/20/0293
- Conditions
- Allergy and Immunology
- Keywords
- IgE assay, food allergy/ hypersensitivity, respiratory allergy/ hypersensitivity, hymenopter allergy/ hypersensitivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,376 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with sensitization or allergy | – | Biological: collection of blood and urineblood and urine will be collected during a blood test scheduled for the follow-up of the patient |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients followed at the Toulouse University Hospital and presenting sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug
Key inclusion criteria (6 listed)
- Males or females 6 months' old or older
- Sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug proven by:
- Social coverage up to date
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of blood and urineblood and urine will be collected during a blood test scheduled for the follow-up of the patient | Biological | People with sensitization or allergy |
Primary outcome
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
2 secondary outcomes
To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA
Time frame: Day 0
To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marine Michelet, MD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Immunology, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine Michelet, MD (33-5 34 55 85 85, michelet.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.