Clinical trial NCT06037967: Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
Official title: Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergic Diseases
Asthma
Mast Cell Disorders
Keywords: Allergy
asthma
mast cell disorders
biomarkers
biobank
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with respiratory disease or allergic disease or mast cell disorders

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
timeFrame: 15 years
Secondary outcomes:
measure: set of diagnostic and/or prognostic biomarkers
timeFrame: 15 years
measure: set of predictive biomarkers
timeFrame: 15 years
measure: Allergy markers exploration
timeFrame: 15 years
measure: Estimation of concordance of biomarkers
timeFrame: 15 years
measure: Evolution of biomarkers
timeFrame: 15 years
measure: Exploration of biological mechanisms
timeFrame: 15 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Laurent GUILLEMINAULT
Study officials:
affiliation: University Hospital, Toulouse
name: Laurent GUILLEMINAULT, MD
role: PRINCIPAL_INVESTIGATOR
References: