NCT06237803招募中不适用
EMN Prospective Sample Collection Project
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 41
- 主要终点
- Biobank
研究概览
简要总结
This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.
This study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples
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
- •Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+/- EMD), plasma cell leukemia (PCL) (+/- EMD)
- •Subjects are ≥ 18 years old.
- •Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures.
- •Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and
- •subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.
排除标准
- •Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care).
- •Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events.
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule.
结局指标
主要结局
Biobank
时间窗: up to 30 years
Collect biological samples for research studies related to improving medicine and care to the patient
次要结局
未报告次要终点
研究者
研究点 (41)
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