- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06037967
Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders (BIRD-A)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laurent GUILLEMINAULT, MD
- Phone Number: 05 67 77 17 51
- Email: guilleminault.l@chu-toulouse.fr
Study Locations
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-
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Toulouse, France, 31059
- Recruiting
- Laurent GUILLEMINAULT
-
Contact:
- Laurent GUILLEMINAULT, MD
- Phone Number: 05 67 77 17 51
- Email: guilleminault@chu-toulouse.fr
-
Sub-Investigator:
- Cristina LIVIDEANU, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- patients under legal protection, guardianship or curatorship
- pregnant or breastfeeding women
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
Time Frame: 15 years
|
constitution of a clinico-biological biobanking
|
15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
set of diagnostic and/or prognostic biomarkers
Time Frame: 15 years
|
identify new set of diagnostic and/or prognostic biomarkers
|
15 years
|
set of predictive biomarkers
Time Frame: 15 years
|
Identify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.
|
15 years
|
Allergy markers exploration
Time Frame: 15 years
|
Explore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).
|
15 years
|
Estimation of concordance of biomarkers
Time Frame: 15 years
|
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.
|
15 years
|
Evolution of biomarkers
Time Frame: 15 years
|
Study the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the clinical-biological bank.
|
15 years
|
Exploration of biological mechanisms
Time Frame: 15 years
|
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
|
15 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurent GUILLEMINAULT, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/23/0173
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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