Remote Breast Cancer Screening Based on Automated Breast Ultrasound Among Chinese Women: a Multi-center, Prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,333
- 试验地点
- 2
- 主要终点
- The performance of breast cancer screening based on AB US with remote reading mode
研究概览
简要总结
A multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on Automated Breast Ultrasound (AB US) with remote reading mode.
详细描述
The burden of breast cancer incidence and mortality is rapidly growing during the past two decades in China. Screening has been proven to be effective in detecting early-stage disease and reducing mortality of 10% to 39% due to breast cancer. US is used as a primary screening method among Chinese women because Asian women characteristically have higher-density breasts than other ethnic groups. However, US is dependent on operator experience, lack of standardized scanning protocols, limited ultrasound physician and heavy workloads. In order to improve the efficiency and quality of breast cancer screening among Chinese women, a new remote screening pattern based on AB US was proposed and studied for breast cancer in China. This multi-center, prospective, cohort study aims to evaluate the efficiency of breast cancer screening based on AB US with remote reading mode. In addition, we will also explore the practice value of AI on AB US screening and efficient image acquiring and reading modes of AB US.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any age at 35 and over
- •Screening breast cancer with AB US
- •Obtaining written informed consent
排除标准
- •symptoms of breast cancer
- •surgical of breast within 12 months prior to the study
- •known diagnosis breast cancer
- •poor image quality
- •follow-up was less than 12 months
结局指标
主要结局
The performance of breast cancer screening based on AB US with remote reading mode
时间窗: 4 years
The performance of breast cancer screening based on AB US with remote reading mode will be evaluated by cancer detection rate, recall rate, sensitivity, specificity, positive predictive value, early detection of breast cancer, interval cancers and time for image acquisition and interpretation.
次要结局
- Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode(4 years)
- Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode(4 years)
- Evaluate the performance of breast cancer screening according to the breast US device(4 years)
研究者
Song Hongping
Principal Investigator
The First Affiliated Hospital of the Fourth Military Medical University