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临床试验/NCT00461253
NCT00461253已完成不适用

Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

Center for Epidemiology and Health Research, Germany1 个研究点 分布在 1 个国家目标入组 25,565 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25,565
试验地点
1
主要终点
Breast Cancer Risk

研究概览

简要总结

The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.

详细描述

This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.

Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.

Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.

A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.

Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.

研究设计

研究类型
Observational
观察模型
Case Control

入排标准

年龄范围
— 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
  • •controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview

排除标准

  • •women who are not willing to participate

结局指标

主要结局

Breast Cancer Risk

时间窗: retrospective, January 2000 to December 2007

Breast cancer (invasive carcinoma or carcinoma in situ) in women aged \<50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.

次要结局

未报告次要终点

研究者

发起方
Center for Epidemiology and Health Research, Germany
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juergen Dinger, MD, PhD

Principal Investigator

Center for Epidemiology and Health Research, Germany

研究点 (1)

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