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NCT Number: NCT06037967

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laurent GUILLEMINAULT

Toulouse, 31059, France

Location status: Recruiting

Location contact

Cristina LIVIDEANU, MD

SUB_INVESTIGATOR

Laurent GUILLEMINAULT, MD

CONTACT

[email protected]

05 67 77 17 51

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders

    Time frame: 15 years

    constitution of a clinico-biological biobanking

Secondary outcomes

  1. set of diagnostic and/or prognostic biomarkers

    Time frame: 15 years

    identify new set of diagnostic and/or prognostic biomarkers

  2. set of predictive biomarkers

    Time frame: 15 years

    Identify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.

  3. Allergy markers exploration

    Time frame: 15 years

    Explore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).

  4. Estimation of concordance of biomarkers

    Time frame: 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.

  5. Evolution of biomarkers

    Time frame: 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.

  6. Exploration of biological mechanisms

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent GUILLEMINAULT, MD

CONTACT

[email protected]

05 67 77 17 51

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: BIRD-A

Important dates

Study start
2024
Primary completion
2038
Study completion
2038
First posted
Sep 14, 2023
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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