Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25,565
- Locations
- 1
- Primary Endpoint
- Breast Cancer Risk
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
Eligibility Criteria
- Ages
- — to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •women who are not willing to participate
Outcomes
Primary Outcomes
Breast Cancer Risk
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Juergen Dinger, MD, PhD
Principal Investigator
Center for Epidemiology and Health Research, Germany