Center for Epidemiology and Health Research
Berlin, 10115, Germany
NCT Number: NCT00461253
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.
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Notify MeUp to 50 year
Female
Observational
Berlin, 10115, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
Other names: Mirena
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
Time frame: 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.
Center for Epidemiology and Health Research, Germany
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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