A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 82,440
- 试验地点
- 1
- 主要终点
- Absolute difference in early-stage breast cancer diagnosis rate
研究概览
简要总结
This multicenter study aims to evaluate whether active breast ultrasound screening can improve the early diagnosis rate of breast cancer in women aged 65 to 80 years, compared with routine elderly health management. The study uses a mixed cluster-individual randomized design based on community implementation capacity. A subgroup of pilot communities will simultaneously collect ultrasound AI data for research performance analysis only, without affecting clinical diagnosis.
详细描述
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 65-80 years.
- •Local residents living in participating communities for ≥6 months.
- •Signed informed consent and willingness to participate.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standardized Breast Ultrasound Screening (Procedure)
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.
结局指标
主要结局
Absolute difference in early-stage breast cancer diagnosis rate
时间窗: 24 months after enrollment
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.
次要结局
- Overall breast cancer detection rate(24 months)
研究者
Qiang Ding
Professor
The First Affiliated Hospital with Nanjing Medical University