BE.Amycon Biobank & Data Registry UZ Leuven
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: Amyloidosis, AL Amyloidosis, Amyloidosis Cardiac. Базовые параметры: от 18 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
BE.Amycon Biobank & Data Registry UZ Leuven: Human Body Material (HBM) Collection and Data Collection of Patients With Amyloidosis
Обзор
The goal of this study is to collect and store human body material (HBM) of patients with amyloidosis in a biobank "BE.Amycon biobank" for future research and to collect clinical data of patients with amyloidosis in a database "BE.Amycon data registry".
Подробное описание
With the support of VIB (Vlaams Instituut voor Biotechnologie) Grand Challenges Program, this project aims to establish the BElgian AMYloidosis CONsortium (BE.AMYCON) by joining forces of VIB researchers, a state-of-the-art diagnostic platform, and clinicians from various disciplines and different institutes. Such a consortium will address patient needs and improve outcomes on many levels.
The aim is is to establish a GDPR (General Data Protection Regulation)-proof HBM biobank in the context of amyloidosis. HBM of patients with suspected or confirmed amyloidosis will be prospectively collected and stored for future scientific research. In addition to the HBM collection, a database with personal and health data of patients diagnosed with amyloidosis (any subtype) will be established in order to get better insights on the disease presentation, disease evolution pattern, treatment plans and responses and survival.
Первичные конечные точки
- Establishment of a data registry: participant baseline demographics [Срок оценки: Baseline]
- Establishment of a data registry: description of the disease characteristics of patients with amyloidosis at diagnosis [Срок оценки: Baseline]
- Establishment of a data registry: treatment in participants with amyloidosis [Срок оценки: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years]
- Establishment of a biobank with biological samples (blood, urine, tissue) from patients with amyloidosis [Срок оценки: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 2 years]
Вторичные конечные точки (5)
- Best Response [Срок оценки: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years]
- Duration of response [Срок оценки: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years.]
- Time to Next Treatment (TTNT) [Срок оценки: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years.]
- Overall Survival (OS) [Срок оценки: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years]
- Progression-free survival (PFS) [Срок оценки: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years]
Критерии участия
Критерии включения
- Provide consent and sign informed consent form
- Age 18 years or older
- Diagnosis of amyloidosis (suspected or confirmed, any subtypes)
- For the prospective sample collection only: newly diagnosed (any subtype) or at relapse (AL amyloidosis)
Критерии исключения
- Not willing to sign informed consent
- Not able to sign informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 2 центра
- UZ Leuven Gasthuisberg - hematology — Leuven
- UZ Leuven Gasthuisberg - cardiology — Leuven
Идентификаторы
NCT: NCT07172243 · BE.AMYCON_UZL_WP2_02