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

Asthma Clinical Trial

— BIRD-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037967
• Other study ID #: RC31/23/0173
• Status: Recruiting
• Start date: February 28, 2024
• Est. completion date: June 2038

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: Laurent GUILLEMINAULT, MD
• Phone: 05 67 77 17 51
• Email: guilleminault.l[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: June 2038
• Est. primary completion date: May 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Diseases
• Asthma
• Respiration Disorders
• Respiratory Tract Diseases

Locations

Country	Name	City	State
France	Laurent GUILLEMINAULT	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders	constitution of a clinico-biological biobanking	15 years
Secondary	set of diagnostic and/or prognostic biomarkers	identify new set of diagnostic and/or prognostic biomarkers	15 years
Secondary	set of predictive biomarkers	Identify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.	15 years
Secondary	Allergy markers exploration	Explore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).	15 years
Secondary	Estimation of concordance of biomarkers	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.	15 years
Secondary	Evolution of biomarkers	Study the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the clinical-biological bank.	15 years
Secondary	Exploration of biological mechanisms	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	15 years