NCT01543126终止不适用
A Prospective Study Assessing the Correlation Between Disease Prognosis and the Level of IL-6 and IL-8 Level in Blood and Pleural Effusion Before and After Chemotherapy in Patients With Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- level of IL-6 and IL-8
研究概览
简要总结
Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease
详细描述
To assess the correlation between the disease prognosis and the level of IL-6 and IL-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 70 years old;
- •Patients with histologic proved metastatic breast cancer;
- •Pleural effusion with the volume of more than 1000ml, as documented by CT, X ray or ultrasound;
- •There are no other diseases which cause the elevation of IL-6 or IL-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis;
- •With at least one measurable disease according to RECIST criteria,
- •Normal laboratory results:ANC≥2.0×109/L,Hb≥80g/L,plt≥100×109/L,TB<UNL (<1.5 x UNL in patients with liver mets),ALT/AST< 1.5 x UNL (<2.5x UNL in patients with liver mets),AKP<5 x UNL(except bone mets),Cr<UNL;
- •Normal functions with heart, liver,renal and bone marrow;
- •Got ICF before enrollment;
- •Life expectancy more than 12 weeks.
排除标准
- •Pregnant or breast-feeding women or positive serum pregnancy test;
- •Uncontrolled brain metastases;
- •No recovery from previous radiation or accepted radiation within 4 weeks before enrollment;
- •Participation in any investigational drug study within 4 weeks preceding treatment start;
- •Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin;
- •Serious uncontrolled intercurrent infections;
- •Poor compliance.
结局指标
主要结局
level of IL-6 and IL-8
时间窗: 2 days
次要结局
未报告次要终点
研究者
Xichun Hu
Principal Investigator
Fudan University
研究点 (1)
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