NCT01322893已完成不适用
Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To determine whether numbers of circulating tumour cells in peripheral blood can give information of prognosis, and to evaluate if the numbers of circulating tumour cells can give information of the efficacy of given treatment
研究概览
简要总结
Women with metastatic breast cancer, receiving first line treatment of any kind (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this trial. In connection to treatment, blood samples for determination and enumeration of circulating tumour cells will be collected at different time points. Serum and plasma will be collected and stored for future analysis of RNA and DNA.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with metastatic breast cancer
- •ECOG performance status 0-2
- •Age over18 years
- •Signed informed concent
- •Predicted life expectancy over 2 months
- •Planned for first line systemic treatment for metastatic disease (chemotherapy, antibody treatment or endocrine treatment)
- •Standard imaging evaluation within 4 weeks of inclusion
- •Planned for standard imaging within 16 weeks after start of therapy
排除标准
- •Prior medical therapy for metastatic disease (prior adjuvant chemotherapy, radiotherapy or endocrine therapy is permitted)
- •Inability to understand information about the study
- •Other malignant disease with the exception of curatively treated basal cell or squamous cell cancer of the skin and cancer in situ of the cervix
结局指标
主要结局
To determine whether numbers of circulating tumour cells in peripheral blood can give information of prognosis, and to evaluate if the numbers of circulating tumour cells can give information of the efficacy of given treatment
时间窗: Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.
次要结局
未报告次要终点
研究者
研究点 (1)
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