A Multicenter Cluster Randomized Controlled Trial on the Necessity of Breast Cancer Ultrasound Screening in Elderly Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80,000
- 试验地点
- 3
- 主要终点
- Absolute difference in early-stage breast cancer diagnosis rate
研究概览
简要总结
This multicenter, cluster randomized trial will evaluate whether community-based breast ultrasound screening improves the early detection of breast cancer in women aged 65 to 80 years, compared with routine health management. Approximately 80,000 women in Jiangsu Province, China, will be enrolled and followed for breast cancer outcomes.
详细描述
This is a multicenter, open-label, cluster randomized controlled trial in Jiangsu Province, China. Approximately 80,000 women aged 65 to 80 years will be enrolled. Participating community health service stations will be assigned to either active breast ultrasound screening or routine health management. Women in the screening group will receive a standardized breast ultrasound examination, while those in the control group will receive no additional study-specific breast screening. The primary outcome is the difference between groups in the proportion of diagnosed breast cancers that are stage I or II during 24 months of follow-up. The study will also assess other screening-related and implementation outcomes.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 筛查
- 盲法
- 单盲 (结局评估者)
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 assigned to this group through their community health service station receive one standardized breast ultrasound examination performed by a qualified physician. Abnormal findings are managed according to routine clinical practice.
干预措施: Standardized Breast Ultrasound Screening (Diagnostic Test)
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
The between-group absolute difference in the proportion of pathologically confirmed breast cancer cases diagnosed at stage I or II.
次要结局
- Overall breast cancer detection rate(24 months)
- Late-stage breast cancer diagnosis rate(Up to 24 months after enrollment)
- Breast biopsy rate(Up to 24 months after enrollment)
研究者
Qiang Ding
Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (3)
标识符
- NCT 编号
- NCT07698366
- 其他研究编号
- JS-BC-Elder-Screen-2026, 2024ZD0524000, 2024ZD0524004, 2025ZD0545404
日期
- 首次提交
- (2个月前)
- 首次发布
- (2个月前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Individual participant data will not be shared because there is currently no approved data sharing policy for this multicenter study. De-identified participant data will be managed in accordance with institutional regulations and applicable ethical and legal requirements.