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The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer
This study is currently recruiting participants.
Verified by National Institute of Environmental Health Sciences (NIEHS), October 2006
Sponsored by: National Institute of Environmental Health Sciences (NIEHS)
Information provided by: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00047970
  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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
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 as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 50000
Study Start Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Women who are eligible for the Sister Study:

  • Have a sister (living or deceased) who had breast cancer
  • Ages 35-74
  • Never had breast cancer themselves
  • Live in the United States

The Sister Study is currently recruiting sisters of women diagnosed with breast cancer nationwide.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047970

Locations
United States, North Carolina
NIEHS Recruiting
Research Triangle Park, North Carolina, United States, 27514
Contact: Dale P Sandler, PhD     919-541-4668     sandler@niehs.nih.gov    
Contact: Sara Williams, MA     919-941-9344     Willia50@niehs.nih.gov    
Principal Investigator: Dale P Sandler, PhD            
Sub-Investigator: Clarice R Weinberg, PhD            
Sponsors and Collaborators
  More Information

Sister Study Website  This link exits the ClinicalTrials.gov site

Study ID Numbers: 02-E-N-271
Study First Received: October 23, 2002
Last Updated: October 25, 2006
ClinicalTrials.gov Identifier: NCT00047970  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Breast Cancer
Sisters

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 30, 2009