NCT02800954已完成不适用
Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 3
- 主要终点
- Serum Macrophage-Colony Stimulating Factor (M-CSF) levels
研究概览
简要总结
The Primary objective of this study is to compare serum levels of Macrophage-Colony Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in a control population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the multiple myeloma group
- •confirmed diagnosis of de novo multiple myeloma according to the International Myeloma Working Group criteria
- •bisphosphonate therapy for more than 60 days,
- •signature of the informed consent form,
- •patients over the age of 18 years. For the monoclonal gammopathy of undetermined significance (MGUS) group
- •confirmed diagnosis of MGUS according to the International Myeloma Working Group criteria
- •signature of the informed consent form,
- •patients over the age of 18 years. For the healthy control group
- •signature of the informed consent form,
- •subjects over the age of 18 years.
排除标准
- •patients with thyroid or parathyroid disease,
- •osteomalacia, rheumatoid arthritis, Paget's disease, osteoporosis,
- •bisphosphonate therapy for less than 60 days,
- •absence of informed consent,
- •patients under the age of 18 years.
研究组 & 干预措施
multiple myeloma group
Experimental
case group = patients with multiple myeloma
干预措施: blood samples (Biological)
multiple myeloma group
Experimental
case group = patients with multiple myeloma
干预措施: Bone marow samples (Biological)
MGUS group
Experimental
monoclonal gammopathy of undetermined significance
干预措施: blood samples (Biological)
MGUS group
Experimental
monoclonal gammopathy of undetermined significance
干预措施: Bone marow samples (Biological)
healthy control group
Other
control group = healthy subjects
干预措施: blood samples (Biological)
结局指标
主要结局
Serum Macrophage-Colony Stimulating Factor (M-CSF) levels
时间窗: Day 1
次要结局
- Tumour osteolysis(Day 1)
研究者
研究点 (3)
Loading locations...
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