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

Last updated: April 29, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT06037967
RC31/23/0173
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 testor specific IgE or a food or drug reintroduction test as part of the treatment
  • patients with systemic or cutaneous mastocytosis according to the internationalclassification8
  • patients with mast cell activation syndrome according to the internationalclassification8
  • patients with familial hyper-alpha tryptasemia on the presence of variation in thenumber 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 theirparticipation and having freely consented to it in writing before any collection ofsamples or data necessary for the research (no restriction of rights by the judicialauthorities and mastery of the French language).

Exclusion

Exclusion Criteria:

  • patients under legal protection, guardianship or curatorship
  • pregnant or breastfeeding women

Study Design

Total Participants: 3200
Study Start date:
February 28, 2024
Estimated Completion Date:
June 30, 2038

Study 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.

Connect with a study center

  • Laurent GUILLEMINAULT

    Toulouse, 31059
    France

    Active - Recruiting

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