Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70,000
- 试验地点
- 1
- 主要终点
- The detection rate of breast cancer
研究概览
简要总结
The goal of this clinical trial is to learn if robotic ultrasound screening works as well as or better than traditional sonographer-led screening for detecting breast cancer. It will also explore how well participants follow recommended post-screening care. The main questions it aims to answer are:
Does robotic ultrasound screening detect more cases of breast cancer compared to traditional sonographer-led screening? How well do participants follow up on recommended care after robotic ultrasound screening? Researchers will compare robotic ultrasound screening to traditional sonographer-led screening to see if robotic ultrasound works effectively for breast cancer screening.
Participants will:
Receive a breast ultrasound performed either by a robotic system or a human sonographer.
Undergo follow-up management based on their BI-RADS classification.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 35-64 years
- •no history of breast cancer
- •ownership and ability to use a smartphone
- •willingness to participate in the screening program.
排除标准
- •Women who have undergone breast removal surgery;
- •Pregnant and lactating women;
- •Women who have undergone breast cancer screening within the past year;
研究组 & 干预措施
Intervention group: Using an ultrasound robot to screen the subjects
干预措施: Screening of the subjects was conducted using an ultrasonic robot. (Device)
The subjects are scanned with traditional hand-held ultrasound.
The subjects are scanned with traditional hand-held ultrasound.The images are diagnosed by radiologists.
结局指标
主要结局
The detection rate of breast cancer
时间窗: After participating in the screening, the subjects will be followed up for 24 months.
Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.
次要结局
- Cancer type(After participating in the screening, the subjects will be followed up for 24 months.)
- Breast cancer clinical stage(After participating in the screening, the subjects will be followed up for 24 months.)
- The breast cancer biopsy rate(After participating in the screening, the subjects will be followed up for 24 months.)
- The early diagnosis rate(After participating in the screening, the subjects will be followed up for 24 months.)
- Lymph node status(After participating in the screening, the subjects will be followed up for 24 months.)
- Breast cancer screen recall rate(After participating in the screening, the subjects will be followed up for 24 months.)
- All-cause mortality(After participating in the screening, the subjects will be followed up for 24 months.)
- Histological Grading of Breast Cancer(After participating in the screening, the subjects will be followed up for 24 months.)
- The positive predictive value(After participating in the screening, the subjects will be followed up for 24 months.)
- Breast cancer mortality(After participating in the screening, the subjects will be followed up for 24 months.)
- Referral adherence rate(After participating in the screening, the subjects will be followed up for 24 months.)
- Interval cancer incidence(After participating in the screening, the subjects will be followed up for 24 months.)
- Post-screening management adherence(After participating in the screening, the subjects will be followed up for 24 months.)
研究者
Xiaoxv Yin, PhD
Professor
Huazhong University of Science and Technology