Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 99,689
- 试验地点
- 21
- 主要终点
- Detection rate of invasive breast cancers
研究概览
简要总结
This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.
详细描述
The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis.
According to the pre-defined order of both primary endpoints and the primary objective of the study in the planning phase, the initial sample size calculation was based solely on the first primary endpoint (invasive breast cancer detection rate). Given the increasing national and international attention of interval cancers to assess the impact of potential overdiagnosis caused by tomosynthesis, we have planned a sample size increase from 80,000 to 120,000 study participants to achieve a reasonable statistical power for the evaluation of both primary endpoints. The revised sample size calculation was carried out without knowledge of the data from the currently recruiting TOSYMA study, i.e. all planning assumptions were based on external data that do not belong to the ongoing study.
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
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women eligible to participate in the National Mammography Screening Program of Germany
- •Informed decision for mammography screening
- •Written informed consent
- •No prior participation in the TOSYMA trial
排除标准
- •Breast cancer up to 5 years prior to study invitation
- •Previous mammography examination < 12 months,
- •Breast implants
研究组 & 干预措施
DBT+s2D
Digital breast tomosynthesis plus synthesized 2D mammograms
干预措施: DBT+s2D (Diagnostic Test)
2D-FFDM
2D full-field digital mammography
干预措施: 2D-FFDM (Diagnostic Test)
结局指标
主要结局
Detection rate of invasive breast cancers
时间窗: Routine screening visit
Number of women with screening-detected invasive breast cancer divided by the number of all women screened. A screening-detected breast cancer is classified as invasive carcinoma if the pT category (pathological tumor size) of the TNM classification falls into one of the following categories: pT1mic, pT1a, pT1b, pT1c, pT1, pT2, pT3, pT4a, pT4b, pT4c, pT4d, pT4, pTX (for evaluation purpose pTX defines histologically approved invasive breast cancer with missing tumor diameter) or the final pathological categorization has been done after neoadjuvant therapy (ypT), implying an invasive cancer prior to therapy.
Cumulative 24 months incidence of interval cancers
时间窗: 24 months after routine screening visit
The 24 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 24 months interval after a negative screening examination divided by the number of all women with a negative screening result.
次要结局
- Recall rate for further assessment(Routine Screening Visit)
- Cumulative 12 months incidence of interval cancers(12 months after routine screening visit)
- Positive predictive value of recall for further assessment (PPV1)(Routine screening visit)
- Detection rate of ductal carcinoma in situ (DCIS)(Routine screening visit)
- Detection rate of tumor category pT1(Routine screening visit)