ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer

This study is currently recruiting participants.
Study NCT00047970.   Last updated on October 25, 2006.   Information provided by National Institute of Environmental Health Sciences (NIEHS)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer
Official Title  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  Observational
Study Design  Natural History, Longitudinal, Defined Population, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Breast Cancer
Intervention 
MEDLINE PMIDs
Links Sister Study Website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  50000
Start Date  August 2003
Completion Date
Eligibility 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.

Gender Female
Ages 35 Years to 74 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00047970
Organization ID 02-E-N-271
Secondary IDs ††
Study Sponsor  National Institute of Environmental Health Sciences (NIEHS)
Collaborators ††
Investigators 
Information Provided By National Institute of Environmental Health Sciences (NIEHS)
Verification Date October 2006
First Received Date  October 23, 2002
Last Updated Date October 25, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers