Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26,877
- 试验地点
- 1
- 主要终点
- cumulative incidence of T2+ cancers after screening
研究概览
简要总结
Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.
详细描述
The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).
Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.
All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •45-70 years old women invited to breast cancer screening program who accepted to participate
排除标准
- •previous breast cancer diagnosis
- •pregnancy or suspicion of pregnancy
- •presence of BRCA1/2 gene mutation
- •Previous Digital Breast Tomosynthesis performed
- •unable to understand informed consent
- •chemotherapy in progress
- •presence of breast implant
结局指标
主要结局
cumulative incidence of T2+ cancers after screening
时间窗: 2 years
incidence of interval cancers
时间窗: 2 years
次要结局
- Positive Predictive value(baseline)
- Detection rate(2 years)
- recall rate(baseline)
- diagnostic agreement between tomosynthesis and 2d mammography(baseline)
- Detection rate of in situ ductal carcinoma(2 years)
- biopsy rate(baseline)
- self-reported pain and discomfort during mammography(baseline)
- x-ray dose(baseline)