Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Allergic Diseases, Asthma, Mast Cell Disorders. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders [Срок оценки: 15 years]
Вторичные конечные точки (6)
- set of diagnostic and/or prognostic biomarkers [Срок оценки: 15 years]
- set of predictive biomarkers [Срок оценки: 15 years]
- Allergy markers exploration [Срок оценки: 15 years]
- Estimation of concordance of biomarkers [Срок оценки: 15 years]
- Evolution of biomarkers [Срок оценки: 15 years]
- Exploration of biological mechanisms [Срок оценки: 15 years]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- patients under legal protection, guardianship or curatorship
- pregnant or breastfeeding women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Laurent GUILLEMINAULT — Toulouse
Идентификаторы
NCT: NCT06037967 · RC31/23/0173