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临床试验/NCT01081288
NCT01081288进行中(未招募)不适用

Nationwide Cluster-randomised Trial of Extending the NHS Breast Screening Age Range in England

University of Oxford2 个研究点 分布在 1 个国家目标入组 4,000,000 人开始时间: 2009年6月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

DrToralGathani

Associate Professor and Consultant Surgeon

University of Oxford

研究点 (2)

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