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Sister Study

This study is currently recruiting patients.

Sponsored by: National Institute of Environmental Health Sciences (NIEHS)
Information provided by: National Institute of Environmental Health Sciences (NIEHS)

Purpose

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.

Condition
Breast Cancer

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer

Further Study Details: 

Expected Total Enrollment:  50000

Study start: August 2003

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 will be recruited nationally through health professionals, breast cancer advocates, the Internet, and a national advertising campaign. Recruitment strategies will maximize inclusion of minorities and high-risk women.

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.

Eligibility

Ages Eligible for Study:  35 Years   -   74 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Women who are eligible for the Sister Study

The Sister Study is currently recruiting sisters of women diagnosed with breast cancer in ARIZONA, FLORIDA, MISSOURI and RHODE ISLAND. The study will open for national enrollment in Fall 2004.


Location and Contact Information


North Carolina
      NIEHS, Research Triangle Park,  North Carolina,  27514,  United States; Recruiting
Dale P Sandler, PhD  919-541-4668    sandler@neihs.nih.gov 
Sara Williams, MA  919-941-9344    Willia50@niehs.nih.gov 
Dale P Sandler, PhD,  Principal Investigator
Clarice R Weinberg, PhD,  Sub-Investigator

More Information

Sister Study Website

Study ID Numbers:  02-E-N-271
Record last reviewed:  March 2004
Record first received:  October 23, 2002
ClinicalTrials.gov Identifier:  NCT00047970
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-10
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