BE.Amycon Biobank & Data Registry UZ Leuven: Human Body Material (HBM) Collection and Data Collection of Patients With Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 505
- 试验地点
- 1
- 主要终点
- Establishment of a data registry: participant baseline demographics
研究概览
简要总结
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".
详细描述
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Not willing to sign informed consent
- •Not able to sign informed consent
结局指标
主要结局
Establishment of a data registry: participant baseline demographics
时间窗: Baseline
Demographic characteristics of amyloidosis participants will be assessed at baseline.
Establishment of a data registry: description of the disease characteristics of patients with amyloidosis at diagnosis
时间窗: Baseline
Disease characteristics of amyloidosis (disease presentation and symptoms, type of organ involvment, results of diagnostic tests (lab values, imaging, biopsy)) will be collected at moment of diagnosis.
Establishment of a data registry: treatment in participants with amyloidosis
时间窗: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
Description of treatment (type of treatment per line of treatment) of participants with amyloidosis within routine clinical care.
Establishment of a biobank with biological samples (blood, urine, tissue) from patients with amyloidosis
时间窗: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 2 years
Biological samples (blood, urine, tissue) will be collected from patients with amyloidosis.
次要结局
- Progression-free survival (PFS)(From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years)
- Best Response(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(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)(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)(From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years)