AllergyFERIplaqNCT05848986
Study if the Presence of Functional FcERI/RII on the Surface of Human Blood Platelet
An observational study of Allergy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Anaphylactic shock is the most severe expression of immediate hypersensitivity reactions. The mechanisms leading to these reactions are still poorly understood and may involve platelets, especially in the most severe forms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- Flow cytometry
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients assessed in the allergy clinic of the Strasbourg University Hospital
Who may be able to join
- Age > 18 years-old
- With a protein/drug allergy (hymenoptera, arachide, amoxicillin)
- Confirmed by skin tests and/or challenge test
- With specific IgEs
Who cannot join
- Patients who refuse to participate to this study
- Patients unable to consent
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires
Strasbourg, 67091
Charles-Ambroise TACQUARD, +33 3.69.55.16.08, charlesambroise.tacquard@chru-strasbourg.fr
About this study
Anaphylactic shock is the most severe expression of immediate hypersensitivity reactions. The mechanisms leading to these reactions are still poorly understood and may involve platelets, especially in the most severe forms.
The IgE ( ImmunoglobulineE)-mediated mechanism, involving the FcERI(the high-affinity receptor for the Fc region of immunoglobulin E (IgE) receptor present on the surface of mast cells and basophilic cells, is the most common mechanism. The receptors FcERI and FcERII are also described as being present on the surface of blood platelets, which would imply their activation along with the other cells involved. However, studies showing the presence of the FcERI/RII receptors on blood platelets suffer from many biases.
The main objective of the research is to study whether the FcERI/RII receptors are present and functional on the surface of blood platelets from allergic patients.
- Conditions
- Allergy
- Being tested
- Flow cytometry
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometryOther
Analysis of blood samples from a health sample's allergic patients and analysis with flow cytometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of functionnal FcERI/RII receptors on the surface of blood platelets from allergic patients
After confirmation of the allergy by a well conducted allergy workup
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHARLES AMBROISE TACQUARD, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848986
- Sponsor's protocol ID
- 8947
- Acronym
- FERIplaq
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 8 May 2023
- 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 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study if the Presence of Functional FcERI/RII on the Surface of Human Blood Platelet
- ClinicalTrials.gov ID
- NCT05848986
- Acronym / sponsor ID
- FERIplaq / 8947
- Conditions
- Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 8 May 2023 (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.
Anaphylactic shock is the most severe expression of immediate hypersensitivity reactions. The mechanisms leading to these reactions are still poorly understood and may involve platelets, especially in the most severe forms.
The IgE ( ImmunoglobulineE)-mediated mechanism, involving the FcERI(the high-affinity receptor for the Fc region of immunoglobulin E (IgE) receptor present on the surface of mast cells and basophilic cells, is the most common mechanism. The receptors FcERI and FcERII are also described as being present on the surface of blood platelets, which would imply their activation along with the other cells involved. However, studies showing the presence of the FcERI/RII receptors on blood platelets suffer from many biases.
The main objective of the research is to study whether the FcERI/RII receptors are present and functional on the surface of blood platelets from allergic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assessed in the allergy clinic of the Strasbourg University Hospital
Key inclusion criteria (4 listed)
- Age > 18 years-old
- With a protein/drug allergy (hymenoptera, arachide, amoxicillin)
- Confirmed by skin tests and/or challenge test
- With specific IgEs
Key exclusion criteria (2 listed)
- Patients who refuse to participate to this study
- Patients unable to consent
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 |
|---|---|---|
| Flow cytometryAnalysis of blood samples from a health sample's allergic patients and analysis with flow cytometry | Other | – |
Primary outcome
Presence of functionnal FcERI/RII receptors on the surface of blood platelets from allergic patients
Time frame: 1 day
After confirmation of the allergy by a well conducted allergy workup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- 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. This study is not recruiting at the moment.
CHARLES AMBROISE TACQUARD, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by University Hospital, Strasbourg, France at 1 site 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHARLES AMBROISE TACQUARD, MD (03 69 55 16 08, charlesambroise.tacquard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of functionnal FcERI/RII receptors on the surface of blood platelets from allergic patients (time frame: 1 day). 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 8 May 2023.