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Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders

Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06037967
Acronym
BIRD-A
Enrollment
3200
Registered
2023-09-14
Start date
2024-02-28
Completion date
2038-06-30
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Diseases, Asthma, Mast Cell Disorders

Keywords

Allergy, asthma, mast cell disorders, biomarkers, biobank

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders15 yearsconstitution of a clinico-biological biobanking

Secondary

MeasureTime frameDescription
set of predictive biomarkers15 yearsIdentify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.
Allergy markers exploration15 yearsExplore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).
set of diagnostic and/or prognostic biomarkers15 yearsidentify new set of diagnostic and/or prognostic biomarkers
Evolution of biomarkers15 yearsStudy the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the clinical-biological bank.
Exploration of biological mechanisms15 yearsExplore 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
Estimation of concordance of biomarkers15 yearsEstimate 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.

Countries

France

Contacts

Primary ContactLaurent GUILLEMINAULT, MD
guilleminault.l@chu-toulouse.fr05 67 77 17 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026