What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60,000
- 试验地点
- 6
- 主要终点
- To compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals
研究概览
简要总结
Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.
详细描述
According to the 2006 European guidelines, the target age for mammography screening is 50-69 years. For women aged 40-49, effectiveness is less and less certain. For those over 70, the most important concern is overdiagnosis. In Europe, so far, both age groups have been invited to screen only in a few countries and regional areas, including some Italian regions. Recently, new European guidelines have been published, developed in the framework of the European Commission Initiative on Breast Cancer. Although with caution, they recommend screening for both women aged 45-49 and those aged 70-74. The recommended interval is 2 or 3 years in the first case and 3 years in the second. The quality of the evidence on which these recommendations are based is defined as very low. Particularly for women aged 45-49, the new European guidelines indicate the need for a research effort, based on comparative studies, on the effectiveness of different screening intervals. This responsibility also falls on Italy, which is the only European country where women aged 45-49 are invited on an annual basis. Therefore, a research project is proposed which includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.
To define the best interval for screening women 45-49 years old a three-arm multicenter randomized non-inferiority trial will be conducted. Women signing the written informed consent will be randomized with a 1:1:1 ratio to:
Arm 1: 1-year screening interval; Arm 2: 2-year screening interval; Arm 3: tailored screening interval on the basis of breast density. Women with very dense breast (Breast Imaging-Reporting and Data System -BI-RADS- category D) will be referred to 1-year interval whereas women with less dense breast to 2-year interval (Breast Imaging-Reporting and Data System -BI-RADS- category A, B, C).
Enrollment will last 2.5 years and all women will be followed for 6 years. 60,000 women will be enrolled.
The primary objective is to compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals and this will be evaluated at the end of the 6-year follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women invited for their first or second mammography (45 or 46 y/o) presenting for screening;
- •Willingness and ability to comply with scheduled visits;
- •Written informed consent obtained prior to performing any protocol-related procedures.
排除标准
- •Pregnancy status;
- •Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis;
- •Ascertained heredo-familial risk according to the standard family history used in screening programs;
- •Participation in another clinical trial on BC screening;
- •Inability to provide signed informed consent.
结局指标
主要结局
To compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals
时间窗: 6 years
Cumulative breast cancer risk will computed as the ratio between the number of stage 2 or higher cancers and the total number of women in the arm. The comparison between arms will be performed using the two proportion Z-test. 95% confidence intervals will also be computed
次要结局
- interval Breast Cancer rate(6 years)
- rate of recall with an invasive procedure (biopsy)(6 years)
- prevalence of dense breast in the target population(6 years)
- Participation in screening(6 years)
- contamination proportion (use of mammography) within two screening rounds (in women referred to 2-year interval)(6 years)
- Breast cancer detection(6 years)
- overall recall rate(6 years)
- cumulative Breast Cancer incidence(6 years)
- resource expenditure(6 years)