Ultrasound and Mammography for Screening Breast Cancer in Chinese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47,709
- 试验地点
- 14
- 主要终点
- screening yield
研究概览
简要总结
Early detection of breast cancer through screening has been a common practice in the United States and several European countries for decades.It is effective in reducing the mortality of breast cancer and improving the postoperative quality of life of patients. Mammography has been the standard imaging method for the screening, and in recent years, a supplemental ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed to define an optimal screening strategy that suits Chinese women and the socioeconomics of China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent；
- •residence from community or working units
排除标准
- •pregnancy；
- •lactation；
- •known metastatic cancer；
- •signs or symptoms of breast disease；
- •presence of breast implants, breast surgery within prior 12 months；
- •had mammography or ultrasound exam within prior 12 months
研究组 & 干预措施
group 1
screening with mammography alone
干预措施: mammography (Other)
group 2
screening with ultrasonography alone
干预措施: ultrasound (Other)
group 3
screening with both mammography and ultrasound
干预措施: mammography and ultrasound (Other)
结局指标
主要结局
screening yield
时间窗: 3 years
Sensitivities, specificities, positive predictive values, and negative predictive values
次要结局
- Cost-effectiveness(3 years)