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Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Other Contraceptive Methods


Phase 4
N/A
60 Years
Open (Enrolling)
Female
Breast Cancer Risk

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Trial Information

Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Other Contraceptive Methods


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 60 years of age without known history of malignancies.

Cases are women with a breast cancer who are younger than 60 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 60 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.


Inclusion Criteria:



- cases: women with a breast cancer who are younger than 60 years of age at cancer
diagnosis

- controls: women without a breast cancer diagnosis who are younger than 60 years at
the time of the interview

Exclusion Criteria:

- women who are not willing to participate

Type of Study:

Observational

Study Design:

Observational Model: Case Control

Outcome Measure:

Breast Cancer Risk

Outcome Time Frame:

retrospective until January 2000

Safety Issue:

Yes

Principal Investigator

Juergen C Dinger, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Epidemiology and Health Research

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ZEG2006_02

NCT ID:

NCT00461253

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Breast Cancer Risk
  • breast cancer
  • Breast Neoplasms

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