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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Breast Cancer Cases |
| |
| 2 | Matched Controls for Breast Cancer Cases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel-releasing IUD | Device | This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast Cancer Risk | 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. | retrospective, January 2000 to December 2007 |
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Inclusion Criteria:
Exclusion Criteria:
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Cases will be identified from population-based cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from.
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| Name | Affiliation | Role |
|---|---|---|
| Juergen Dinger, MD, PhD | Center for Epidemiology and Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Epidemiology and Health Research | Berlin | 10115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21310281 | Result | Dinger J, Bardenheuer K, Minh TD. Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer. Contraception. 2011 Mar;83(3):211-7. doi: 10.1016/j.contraception.2010.11.009. Epub 2011 Jan 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis. |
| FG001 | Controls | Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Definitions: cases were defined as women who were diagnised with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis. Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis. |
| BG001 | Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breast Cancer Risk | 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. | Frequency of breast cancer (in situ and invasive) in LNG-IUD users and Cu-IUD users | Posted | Number | participants | retrospective, January 2000 to December 2007 |
|
Retrospective population based case-control study identifying breast cancer cases in the between January 2000 and December 2007 in women younger than 50 years of age at time of diagnosis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LNG IUD | Users of LNG IUDs (Mirena) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Breast cancer (in situ and invasive) |
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Limitations include information-bias, which cannot be entirely eliminated in retrospective studies. However, in this study recall is likely not to be differential between cases and controls.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jürgen Dinger | Center for Epidemiology and Health Research, Germany | 0049 (0) 30 945 101 20 | dinger@zeg-berlin.de |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007435 | Intrauterine Devices, Copper |
| ID | Term |
|---|---|
| D007436 | Intrauterine Devices, Medicated |
| D007434 | Intrauterine Devices |
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
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|
| Copper IUD | Device | This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study. |
|
| no response |
|
| administrative |
|
Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 1,085 |
| 5,346 |
| 0 |
| 5,346 |
| EG001 | Cu-IUD | Users of copper IUDs | 1,130 | 5,428 | 0 | 5,428 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D004864 | Equipment and Supplies |