Hemostatic Profiles Associated With Use of Aromatase Inhibitors and Tamoxifen in Women With Breast Cancer : a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in thrombin generation, including APC sensitivity ratio
研究概览
简要总结
The aim of this prospective cohort study is to evaluate the modifications of the biological hemostatic profile associated with the use of endocrine therapy in women with breast cancer (tamoxifen or aromatase inhibitors).
详细描述
In this cohort study, women with breast cancer and an indication for endocrine therapy will be prospectively enrolled. At the 1st visit (before the start of endocrine therapy (tamoxifen or aromatase inhibitor)) and at the 2nd visit (at ~3 months after the start of treatment), demographical / clinical data and blood samples will be collected. We will evaluate the hemostatic biological profiles associated with the use of endocrine therapy by comparing hemostatic biomarkers before and during its use.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •adult women with a diagnosis of non-metastatic breast cancer and an indication for adjuvant endocrine therapy
排除标准
- •lack of consent
- •planned chemotherapy
- •personal history of venous thromboembolism
- •ongoing anticoagulant treatment
结局指标
主要结局
Change in thrombin generation, including APC sensitivity ratio
时间窗: three months
次要结局
- Change in fibrinolytic time(three months)
- Change in levels of coagulation factors(three months)
研究者
Marc Blondon
Principal Investigator
University Hospital, Geneva