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| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 23, 2002 |
| Last Updated Date | October 25, 2006 |
| Start Date ICMJE | August 2003 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00047970 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer |
| Official Title ICMJE | The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer |
| Brief Summary | The Sister Study will prospectively examine environmental and familial risk factors for breast cancer and other diseases in a cohort of 50,000 sisters of women who have had breast cancer. Such sisters have about twice the risk of developing breast cancer as other women. |
| Detailed Description | The Sister Study will prospectively examine environmental and familial risk factors for breast cancer and other diseases in a cohort of 50,000 sisters of women who have had breast cancer. Such sisters have about twice the risk of developing breast cancer as other women. The frequency of any relevant genes and shared risk factors will also be higher. Studying sisters will enhance our ability to understand the interplay of genes and environment in breast cancer risk and to identify potentially preventable risk factors. We will assess exposures before the onset of disease, thus avoiding biases common to retrospective studies. The study will create a framework from which to test new hypotheses as they emerge. Cancer-free sisters aged 35-74 are being recruited nationally. A total of 29,000 enrolled through October 2006; 21,000 more women are needed. The study aims to include a divers group of women. Women of color, older women, and women who work in trades are especially encouraged to enroll. Additional information about the study and how to enroll can be found at www.sisterstudy.org. Data on potential risk factors and current health status will be collected with telephone interviews and self-completed questionnaires. Blood, urine, and environmental samples will be collected and banked for future use in nested studies of women who develop breast cancer (or other diseases) and a sample of those who don't. The cohort will be followed prospectively for 10 or more years. Annual questionnaires will update medical history and changes in exposures. About 300 new cases of breast cancer are expected to occur in the cohort each year. Analyses will assess the independent and combined effects of environmental exposures and genetic polymorphisms that affect estrogen metabolism, DNA repair, and response to specific environmental exposures. Future analyses will focus on known and potential risk factors (e.g. smoking, occupational exposures, alcohol, diet, obesity) and include measurement of phthalates, phytoestrogens, insulin, growth factors, micro-nutrients, and genes. The cohort will also be used to explore risk for other diseases (e.g. heart disease, osteoporosis, other hormonal cancers, and autoimmune diseases) that are important for women. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Prospective Study |
| Condition ICMJE | Breast Cancer |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Enrollment ICMJE | 50000 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria: Women who are eligible for the Sister Study:
The Sister Study is currently recruiting sisters of women diagnosed with breast cancer nationwide. |
| Gender | Female |
| Ages | 35 Years to 74 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00047970 |
| Responsible Party | |
| Study ID Numbers ICMJE | 02-E-N-271 |
| Study Sponsor ICMJE | National Institute of Environmental Health Sciences (NIEHS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Environmental Health Sciences (NIEHS) |
| Verification Date | October 2006 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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