BIRD-A: Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06037967

Collaborator

(none)

3,200

Enrollment

Location

176

Anticipated Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Diseases Asthma Mast Cell Disorders

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

Study Type:

Observational

Anticipated Enrollment :

3200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

May 1, 2038

Anticipated Study Completion Date :

Jun 1, 2038

Outcome Measures

Primary Outcome Measures

Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders [15 years]
constitution of a clinico-biological biobanking

Secondary Outcome Measures

set of diagnostic and/or prognostic biomarkers [15 years]
identify new set of diagnostic and/or prognostic biomarkers
set of predictive biomarkers [15 years]
Identify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.
Allergy markers exploration [15 years]
Explore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).
Estimation of concordance of biomarkers [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.
Evolution of biomarkers [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.
Exploration of biological mechanisms [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
adults (aged 18 and over)
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).