Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
研究概览
简要总结
Operable early stage breast cancer patients staged according to NCCN guidelines are subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively. Results of the pilot study will be evaluated as observational study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients over 18 years old and who have given informed consent to enter the study.
- •ASA I-II patients
- •Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study
- •Patients who are appropriate for bone marrow biopsy
- •Menopausal status is not relevant.
排除标准
- •Active collagen tissue disorders
- •Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study
- •Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication.
- •Patients who refused to enter the study protocol and refused to give informed consent.
结局指标
主要结局
Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
时间窗: up to 5 years
Rate of sentinel lymph node metastases in early stage breast cancer
时间窗: up to 5 years
Rate of bone marrow metastases in early stage breast cancer
时间窗: up to 5 years
Number of patients with bone marrow metastases/ total number of enrolled patients
Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer
时间窗: up to 5 years
Incidence of bone marrow metastases in triple negative early stage breast cancer
时间窗: up to 5 years
次要结局
- Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy(Up to 10 years)
- Overall survival(up to 10 years)