Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •patients under legal protection, guardianship or curatorship
- •pregnant or breastfeeding women
结局指标
主要结局
Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
时间窗: 15 years
constitution of a clinico-biological biobanking
次要结局
- set of diagnostic and/or prognostic biomarkers(15 years)
- Allergy markers exploration(15 years)
- Exploration of biological mechanisms(15 years)
- set of predictive biomarkers(15 years)
- Evolution of biomarkers(15 years)
- Estimation of concordance of biomarkers(15 years)