Effectiveness of Breast Cancer Screening in Women Aged 40-59: Digital Mammography With Supplemental Breast Ultrasonography Versus Digital Mammography Only
试验速览
- 阶段
- 不适用
- 入组人数
- 11,880
- 试验地点
- 1
- 主要终点
- Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only
研究概览
简要总结
Mammography screening has limited performance in young women or women with dense breasts although it is the only proven method for breast cancer screening that reduces the mortality. The investigators propose a multicenter trial of breast cancer screening to assess the effectiveness of supplemental ultrasonography for Korean women aged 40-59 years.
详细描述
The investigators will screen same consecutive participants using both methods; digital mammography plus supplemental ultrasonography (intervention arm) and digital mammography only (control arm) for 5 years. The investigators will collect follow-up information by assessment of screening records, questionnaire, and official cancer registry. The primary outcome will be sensitivity, specificity, recall rate, cancer detection rate and stage distribution at the end of first round of screening. The secondary outcome will be cost-effectiveness and cost-utility of digital mammography with ultrasonography versus digital mammography only for breast cancer screening. It is hoped that the results of this trial will provide guidance of effective breast cancer screening strategy to women aged 40-59, especially with dense breasts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 40-59 years
- •No history of any cancer
- •No breast mammography (and ultrasonography, in case of intervention arm) after the introduction of digital mammography
排除标准
- •Interstitial injection
- •Women with history of any cancer
结局指标
主要结局
Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only
时间窗: 1 year after the screening
rate of positive results of the screening among histologically proved breast cancer patients
次要结局
- Cost-utility of supplemental ultrasonography of the breast(1 year after the screening)
- Cost-effectiveness of supplemental ultrasonography of the breast(1 year after the screening)
研究者
EUN HYE LEE
Director, Head of Breast Imaging, Principal Investigator, Professor
Soonchunhyang University Hospital