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临床试验/NCT03217539
NCT03217539已完成不适用

The Two-County Swedish Mammography Screening Trial

Dalarna County Council, Sweden0 个研究点目标入组 133,065 人开始时间: 2017年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
133,065
主要终点
Breast cancer death

研究概览

简要总结

Population-based randomized controlled trial carried out in two Swedish counties, Dalarna and Ostergotland to find out the impact of early detection on mortality from breast cancer.

详细描述

The Swedish Two-county study is a randomized controlled trial of invitation to mammography screening. The trial took place in Kopparberg (W), now called Dalarna, and Ostergotland counties in Sweden. The trial randomized 77,080 women aged 40-74 years to invitation to screening (active study population, ASP) and 55,985 women to no invitation to screening (passive study population, PSP). The trial started in 1977 in W-county and in 1978 in E-county. Women in age 40-49 years were invited to single-view mammography screening on average every 24 months, and women aged 50-74 years on average every 33 months. Approximately seven years after randomization a significant 31% decrease in breast cancer mortality was observed in the ASP group, whereupon the PSP was invited to screening once and the screening phase of the trial ended. The mortality data have been reported every two years during the follow-up period and published in peer-reviewed medical journals. The investigators have follow-up data to the Dec 31 2015. The 29-year follow-up data has been published in 2012 in Radiology. Publication of the long-term data reflects the fact that deaths avoided by early detection include some that would have occurred a considerable time later than the screening.

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
40 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 40-74
  • No history of breast cancer

排除标准

  • Breast cancer diagnosis prior to randomization

结局指标

主要结局

Breast cancer death

时间窗: 9 years

Comparison of breast cancer mortality in the ASP versus PSP

次要结局

未报告次要终点

研究者

发起方
Dalarna County Council, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laszlo Tabar, MD, FACR (Hon)

Emeritus Professor

Dalarna County Council, Sweden

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