Nationwide Cluster-randomised Trial of Extending the NHS Breast Screening Age Range in England
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 4,000,000
- 试验地点
- 2
- 主要终点
- Breast cancer mortality
研究概览
简要总结
Nationwide cluster-randomised trial of extending the NHS breast screening age range in England
详细描述
In 1988, the national Breast Screening Programme (BSP) began offering women aged 50-64 years triennial mammographic screening and full national coverage was achieved by the mid-1990s.
In 2003, the age range for triennial screening was extended from 50-64 to 50-70 years; proposals from committees in the Department of Health to randomise this age extension and thereby to obtain reliable information on both the risks and benefits of additional screening at ages 65-70 were not adopted.
Currently, 80 breast screening units cover all of England, each responsible for a defined area, and each year they invite about 2.8 million women aged 50-70, with 2.0 million accepting. The BSP sets standards for the screening units and monitors performance through its national quality assurance network.
In 2007, the Prime Minister announced plans for eventual extension to the range 47-73 years. This offered another opportunity to obtain reliable evidence about the effects of extending the age range of triennial screening. Hence, a trial of this age extension has begun, in which only half are offered extra screening, with the effects monitored through routinely collected NHS statistics.
Following a 2009-10 pilot study of the acceptability of cluster-randomisation of additional screening at ages 47-49 and 71-73 in 5 breast screening units, the AgeX trial extended recruitment to about five-sixths of the breast screening clinics in England, and this cluster-randomisation continues.
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
- 47 Years 至 73 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, and
- •Aged 47-49 years or 71-73 years, and
- •In a Breast Screening Unit participating in the study. (All Breast Screening Units in England are expected to participate in the study with the exception of a few that use non-standard methods for creating screening batches).
排除标准
- •Anyone not satisfying the inclusion criteria
结局指标
主要结局
Breast cancer mortality
时间窗: 17 years
次要结局
- Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported(17 years)
- Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported(17 years)
- Breast cancer treatments, including use of mastectomy, chemotherapy and radiotherapy, up to the same date that the primary outcome (breast cancer mortality) is reported(17 years)
- All-cause mortality, up to the same date that the primary outcome (breast cancer mortality) is reported(17 years)
研究者
DrToralGathani
Associate Professor and Consultant Surgeon
University of Oxford
