Allergic DiseasesBIRD-ANCT06037967
Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
An observational study of Allergic Diseases and Asthma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study aims to build up a clinico-biological bank of samples from patients suspected of or suffering from allergic diseases (including asthma) or mast cell diseases in order to support future research in the field of allergic diseases. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Allergic Diseases, Asthma, Mast Cell Disorders
- How many people
- 3,200 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2024to Jun 2038
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with respiratory disease or allergic disease or mast cell disorders
Who may be able to join
- patients with a positive prick test or specific IgE regardless of the allergen
- patients suspected of allergic pathology defined by the need to carry out a prick test or specific IgE or a food or drug reintroduction test as part of the treatment
- patients with systemic or cutaneous mastocytosis according to the international classification8
- patients with mast cell activation syndrome according to the international classification8
- patients with familial hyper-alpha tryptasemia on the presence of variation in the number of copies of the alpha allele of the TPSAB1 gene
- patients with asthma of any severity
- people affiliated or beneficiaries of a social security scheme
- patients able to receive and understand the information on the study and their participation and having freely consented to it in writing before any collection of samples or data necessary for the research (no restriction of rights by the judicial authorities and mastery of the French language).
Who cannot join
- patients under legal protection, guardianship or curatorship
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Laurent GUILLEMINAULT
Toulouse, 31059
Laurent GUILLEMINAULT, MD, 05 67 77 17 51, guilleminault@chu-toulouse.fr
Cristina LIVIDEANU, MD
About this study
This study aims to build up a clinico-biological bank of samples from patients suspected of or suffering from allergic diseases (including asthma) or mast cell diseases in order to support future research in the field of allergic diseases. The biobank will help to identify new prognostic, diagnostic and/or predictive biomarkers.
Read the detailed description
This is a prospective monocentric collection of biological samples combined with clinical and paraclinical data from patients suffering from allergic diseases, asthma or mast cell disorders. The aim of this collection is to collect biological samples and clinical data to be used for various exploratory, diagnostic and/or prospective and/or predictive studies.
The samples and data will be pseudonymised, i.e. identified by the first letter of the patient's surname and first name and by a number allocated in chronological order of patient inclusion, and will be stored in a bank. The samples and data making up this clinico-biological bank will be used for subsequent exploratory work used as a priority to answer questions from the Toulouse University Hospital teams in the field of allergic diseases, asthma and/or mast cell disorders, in accordance with the information given to the patient. They may also be transferred to specialised research teams as part of national or international collaborations, or sold to academic or industrial partners. These transfers as part of collaborations or assignments will be legally governed by contracts guaranteeing compliance with the RGPD, where applicable, and the use of these samples in accordance with current legislation and the information provided to patients.
- Conditions
- Allergic Diseases, Asthma, Mast Cell Disorders
- Keywords
- Allergy, asthma, mast cell disorders, biomarkers, biobank
- Medical subject headings
- Asthma, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
constitution of a clinico-biological biobanking
Measured: 15 years
Secondary outcomes (6)
set of diagnostic and/or prognostic biomarkers
identify new set of diagnostic and/or prognostic biomarkers
Measured: 15 years
set of predictive biomarkers
Identify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.
Measured: 15 years
Allergy markers exploration
Explore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).
Measured: 15 years
Estimation of concordance of biomarkers
Estimate the concordance of the presence of known and/or newly identified biomarkers of interest in the biological sample(s) making up the clinical-biological bank with the clinical data collected.
Measured: 15 years
Evolution of biomarkers
Study the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the clinical-biological bank.
Measured: 15 years
Exploration of biological mechanisms
Explore through molecular and/or genomic and/or transcriptomic and/or proteomic studies the biological mechanisms specific to patients with allergic (including asthma) or mast cell pathologies to improve screening, diagnosis, orientation treatment and/or knowledge and understanding of these pathologies
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start28 Feb 2024
- Primary completionMay 2038 (estimated)
- Study completionJun 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent GUILLEMINAULT, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037967
- Sponsor's protocol ID
- RC31/23/0173
- Acronym
- BIRD-A
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
- ClinicalTrials.gov ID
- NCT06037967
- Acronym / sponsor ID
- BIRD-A / RC31/23/0173
- Conditions
- Allergic Diseases, Asthma, Mast Cell Disorders
- Keywords
- Allergy, asthma, mast cell disorders, biomarkers, biobank
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- May 2038 (estimated)
- Study completion
- Jun 2038 (estimated)
- First posted
- 14 Sep 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.
This study aims to build up a clinico-biological bank of samples from patients suspected of or suffering from allergic diseases (including asthma) or mast cell diseases in order to support future research in the field of allergic diseases. The biobank will help to identify new prognostic, diagnostic and/or predictive biomarkers.
Detailed description
This is a prospective monocentric collection of biological samples combined with clinical and paraclinical data from patients suffering from allergic diseases, asthma or mast cell disorders. The aim of this collection is to collect biological samples and clinical data to be used for various exploratory, diagnostic and/or prospective and/or predictive studies.
The samples and data will be pseudonymised, i.e. identified by the first letter of the patient's surname and first name and by a number allocated in chronological order of patient inclusion, and will be stored in a bank. The samples and data making up this clinico-biological bank will be used for subsequent exploratory work used as a priority to answer questions from the Toulouse University Hospital teams in the field of allergic diseases, asthma and/or mast cell disorders, in accordance with the information given to the patient. They may also be transferred to specialised research teams as part of national or international collaborations, or sold to academic or industrial partners. These transfers as part of collaborations or assignments will be legally governed by contracts guaranteeing compliance with the RGPD, where applicable, and the use of these samples in accordance with current legislation and the information provided to patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with respiratory disease or allergic disease or mast cell disorders
Key inclusion criteria (8 listed)
- patients with a positive prick test or specific IgE regardless of the allergen
- patients suspected of allergic pathology defined by the need to carry out a prick test or specific IgE or a food or drug reintroduction test as part of the treatment
- patients with systemic or cutaneous mastocytosis according to the international classification8
- patients with mast cell activation syndrome according to the international classification8
- patients with familial hyper-alpha tryptasemia on the presence of variation in the number of copies of the alpha allele of the TPSAB1 gene
Key exclusion criteria (2 listed)
- patients under legal protection, guardianship or curatorship
- pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
Time frame: 15 years
constitution of a clinico-biological biobanking
6 secondary outcomes
set of diagnostic and/or prognostic biomarkers
Time frame: 15 years
set of predictive biomarkers
Time frame: 15 years
Allergy markers exploration
Time frame: 15 years
Estimation of concordance of biomarkers
Time frame: 15 years
Evolution of biomarkers
Time frame: 15 years
Exploration of biological mechanisms
Time frame: 15 years
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 1 May 2024.
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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.
Laurent GUILLEMINAULT, MD principal investigator
University Hospital, Toulouse
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 Allergic Diseases and Asthma, run by University Hospital, Toulouse 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 8 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: looking for participants now, as of the sponsor's last update on 1 May 2024. 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?
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 Laurent GUILLEMINAULT, MD (05 67 77 17 51, guilleminault.l@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders (time frame: 15 years). 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 1 May 2024.