BE.Amycon Amyloidosis Data Registry UZ Leuven
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Participant baseline demographics
研究概览
简要总结
The goal of this observational study is to establish database with (limited) personal and health data of patients diagnosed with amyloidosis (any subtype) in order to get better insights on the disease presentation, disease evolution pattern, treatment plans and responses and survival.
详细描述
With the support of VIB 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.
In this context, a registry of clinical data is a requirement for both improvement of diagnostics as well as fundamental research purposes.
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
- 否
入选标准
- •Age 18 years or older
- •Provide consent and sign informed consent form
- •Confirmed diagnosis of amyloidosis (any subtype), systemic and/or localised
- •Newly diagnosed or in follow-up during the study time-frame (1 JUN 2025 until 31 DEC 2027)
排除标准
- •Not able to provide informed consent
- •Not willing to sign informed consent
结局指标
主要结局
Participant baseline demographics
时间窗: Baseline
Demographic characteristics of amyloidosis participants will be assessed at baseline.
Participant amyloidosis diagnosis information
时间窗: Baseline
Disease characteristics will be collected at moment of diagnosis.
Sequence of treatments 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
Treatment sequences for participants with amyloidosis within routine clinical care will be assessed.
次要结局
- 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)
- 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)