Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Allergic Diseases, Asthma, Mast Cell Disorders. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders [Time frame: 15 years]
Secondary outcome measures (6)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Laurent GUILLEMINAULT — Toulouse
Identifiers
NCT: NCT06037967 · RC31/23/0173