Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 21,000
- 试验地点
- 1
- 主要终点
- the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China
研究概览
简要总结
Objective: To investigate the current clinical practice of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China. Methods: The data of early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018 will be collected. Different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of SLNB and the follow-up treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •breast cancer confirmed by fine needle aspiration or biopsy
- •SLNB with or without axillary lymph node dissection
- •receiving conventional systematic treatment or regional treatment
- •complete medical record.
排除标准
- •IV stage breast cancer
- •combined with secondary invasive malignant tumor
- •diagnosed with other serious disease, including congestive heart failure (NYHA cardiac function grade II, III, IV) or congestive heart failure, unstable angina pectoris, myocardial infarction, high-risk uncontrollable heart rate disorder or other serious cardiovascular diseases within 6 months
- •difficulty breathing at rest or need oxygen therapy
- •severe infection
- •uncontrolled diabetes
- •serious psychological or mental disorders
- •poor compliance.
结局指标
主要结局
the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China
时间窗: 2020-12-31
the performance rate of SLNB refers to the number of patients implementing SLNB divided by the total number of breast cancer patients
the number of resected SLNs in patients with early stage breast cancer in China
时间窗: 2020-12-31
the average number of resected SLNB will be calculated
the positive rate of SLNs in patients with early stage breast cancer in China
时间窗: 2020-12-31
SLNs positive rate is the number of positive SLN patients divided by the number of patients implementing SLNB
次要结局
- incidence of infection events after SLNB in patients with early stage breast cancer in China(2021-12-31)