Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047970
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2002-10-23
Brief Title:
The Sister Study Genetic and Environmental Risk Factors for Breast Cancer
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
The Sister Study Genetic and Environmental Risk Factors for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Sister Study is prospectively examining environmental and familial risk factors for breast cancer and other diseases in a cohort of 50884 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 50884 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 50884 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 dont 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 eg 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 eg heart disease osteoporosis other hormonal cancers and autoimmune diseases that are important for women
Cancer-free sisters aged 35-74 were recruited nationally Enrollment was completed July 2009 with 50884 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 dont 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 eg 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 eg heart disease osteoporosis other hormonal cancers and autoimmune diseases that are important for women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None