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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dale Sandler, National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00047970
First received: October 23, 2002
Last updated: November 5, 2012
Last verified: November 2012

October 23, 2002
November 5, 2012
August 2003
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Complete list of historical versions of study NCT00047970 on ClinicalTrials.gov Archive Site
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The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer
The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer

The Sister Study is prospectively examining environmental and familial risk factors for breast cancer and other diseases in a cohort of 50,884 sisters of women who have had breast cancer. Such sisters have about twice the risk of developing breast cancer as other women.

The Sister Study is prospectively examining environmental and familial risk factors for breast cancer and other diseases in a cohort of 50,884 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 enhances our ability to understand the interplay of genes and environment in breast cancer risk and to identify potentially preventable risk factors. We assess exposures before the onset of disease, thus avoiding biases common to retrospective studies. The assembled cohort has created a framework from which to test new hypotheses as they emerge.

Cancer-free sisters aged 35-74 were recruited nationally. Enrollment was completed July 2009 with 50,884 women fully enrolled. Participants have enrolled from all 50 states and Puerto Rico. The cohort is now being followed actively. Cohort members are occasionally invited to participate in add-on studies, which sometimes include asking participants to invite their family members to provide information.

Data on potential risk factors and current health status were collected with telephone interviews and self-completed questionnaires. Blood, urine, and environmental samples were 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 is being followed prospectively for 10 or more years. Annual questionnaires update medical history and changes in exposures. About 300 new cases of breast cancer are expected to occur in the cohort each year. Analyses are ongoing and 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. Women who develop breast cancer during the study are followed to assess the role of environment and genes in healthy survival following diagnosis and treatment. 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.

Observational
Time Perspective: Prospective
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Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50000
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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.

Female
35 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047970
02-E-N-271
No
Dale Sandler, National Institute of Environmental Health Sciences (NIEHS)
National Institute of Environmental Health Sciences (NIEHS)
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National Institute of Environmental Health Sciences (NIEHS)
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP