Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,156
- 试验地点
- 5
- 主要终点
- advanced cancer incidence
研究概览
简要总结
Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.
详细描述
This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.
In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).
The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.
The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.
Women will be asked for informed consent when they attend the mammography. If they accept they will be randomised to one of the two arms.
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)
盲法说明
It is not possible to mask the intervention for the patient, care provider, and investigator.
Only the assessment of one of the two co-primary outcomes, i.e. cumulative incidence of advanced breast cancer after the first round of screening, can be masked. This will be obtained through a blind review of an external panel of pathologists and radiologists reviewing cases retrieved by cancer registries.
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women scheduled for a new round of mammographic screening
- •resident in the province
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
研究组 & 干预措施
Tomosynthesis + synthetic 2D
Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
干预措施: tomosynthesis + synthetic 2D (Diagnostic Test)
Digital Mammography
Women will be screened for digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
干预措施: digital mammography (Diagnostic Test)
结局指标
主要结局
advanced cancer incidence
时间窗: 4 years (+9 months to complete third round assessment)
cumulative incidence of T2+ cancers after first screening round
interval cancer incidence
时间窗: 1 year for 45-49 years old women
incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.
次要结局
- detection rate(This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered)
- recall rate(This outcome is measured at the baseline screening.)
- overall cumulative incidence(4 years (+9 months to complete second round assessment))
- positive predictive value(This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered)
- Detection rate of ductal carcinoma in situ(This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered)
- biopsy rate(This outcome is measured at the baseline screening.)
- reading time(This outcome is measured at the baseline screening.)
- x-ray dose(This outcome is measured at the baseline screening.)