Ultrasound Screening for Early Detection of Breast Cancer in Elderly Women: A Mixed Cluster-Individual RCT
A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening
研究概览
详细说明
This is a multicenter, open-label, mixed cluster-individual randomized controlled trial conducted in Jiangsu Province, China. A total of 82,440 elderly women aged 65-80 years will be enrolled and assigned to either the ultrasound active screening group or the routine health management group. Communities with limited screening capacity will be randomized as clusters, while communities with individual screening conditions will randomize participants individually.
The primary endpoint is the absolute difference in the diagnosis rate of early-stage breast cancer between the two groups within 2 years of follow-up. In pilot communities of the screening group, an ultrasound AI system will be deployed synchronously to verify its diagnostic performance, homogenization effect on primary care physicians, and health economic value. All clinical diagnosis and endpoint adjudication are based on manual ultrasound reports; AI results are only used for retrospective scientific research and do not interfere with clinical decision-making.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ge Ma, doctor
- 电话号码：+8618262632870
- 邮箱：ntmage@sina.com
学习地点
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Jiangsu
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Kunshan、Jiangsu、中国
- Kunshan First People's Hospital
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接触：
- Qin Zhou, doctor
- 电话号码：+86-18626179180
- 邮箱：4527472@qq.com
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参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Female participants aged 65-80 years.
- Local residents living in participating communities for ≥6 months.
- Signed informed consent and willingness to participate.
Exclusion Criteria:
- History of breast cancer or previous breast cancer treatment.
- Breast cancer screening within the past 2 years.
- Severe comorbid conditions that may affect study participation or follow-up.
- Acute breast disease or conditions requiring immediate treatment.
- Unable to cooperate with screening procedures due to physical or cognitive limitations.
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ultrasound Active Screening Group
Participants receive one standardized breast ultrasound examination performed by certified primary care physicians during annual health check-ups.
In selected pilot communities, an ultrasound AI system is deployed synchronously for image data collection and retrospective scientific analysis only; AI results do not affect clinical diagnosis or report issuance.
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Retrospective AI image analysis for research use only, not involved in clinical decision-making.
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无干预：Routine Health Management Group
Participants receive conventional community health management and annual physical examination according to local routine practice, without study-specific breast ultrasound screening.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Absolute difference in early-stage breast cancer diagnosis rate
大体时间：24 months after enrollment
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Proportion of pathologically confirmed breast cancer cases at stage I or stage II, compared between the ultrasound screening group and the routine management group within 2-year follow-up.
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24 months after enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall breast cancer detection rate
大体时间：24 months
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Overall breast cancer detection rate
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24 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- JS-BC-Elder-Screen-2026
- 2024ZD0524000 (其他赠款/资助编号：Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2024ZD0524004 (其他赠款/资助编号：Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2025ZD0545404 (其他赠款/资助编号：Noncommunicable Chronic Diseases-National Science and Technology Major Project)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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