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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 23, 2002
Last Updated Date	November 5, 2012
Start Date ^ICMJE	August 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00047970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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 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.
Detailed Description	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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50000
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00047970
Other Study ID Numbers ^ICMJE	02-E-N-271
Has Data Monitoring Committee	No
Responsible Party	Dale Sandler, National Institute of Environmental Health Sciences (NIEHS)
Study Sponsor ^ICMJE	National Institute of Environmental Health Sciences (NIEHS)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Environmental Health Sciences (NIEHS)
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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