Breast CancerNCT00047970
The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer
An observational study of Breast Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 50,884 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Sisters
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2002 (estimated)
- Study startAug 2003
- Primary completionAug 2009
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50,884 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Dale Sandler, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047970
- Sponsor's protocol ID
- 02-E-N-271
- Status last verified
- Nov 2012
- First submitted
- 23 Oct 2002
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Brien KM, Sandler DP. Reply to "Vitamin D and breast cancer: Stop torturing the data!". Cancer. 2022 Aug 1;128(15):3000-3001. doi: 10.1002/cncr.34274. Epub 2022 Jun 1. No abstract available.
PubMed 35647759Kresovich JK, Park YM, Keller JA, Sandler DP, Taylor JA. Healthy eating patterns and epigenetic measures of biological age. Am J Clin Nutr. 2022 Jan 11;115(1):171-179. doi: 10.1093/ajcn/nqab307.
PubMed 34637497Petimar J, Park YM, Smith-Warner SA, Fung TT, Sandler DP. Dietary index scores and invasive breast cancer risk among women with a family history of breast cancer. Am J Clin Nutr. 2019 May 1;109(5):1393-1401. doi: 10.1093/ajcn/nqy392.
PubMed 30968114
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer
- ClinicalTrials.gov ID
- NCT00047970
- Acronym / sponsor ID
- 02-E-N-271
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Sisters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,884 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Aug 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Derived from this study: PubMed 35647759O'Brien KM, Sandler DP. Reply to "Vitamin D and breast cancer: Stop torturing the data!". Cancer. 2022 Aug 1;128(15):3000-3001. doi: 10.1002/cncr.34274. Epub 2022 Jun 1. No abstract available.
- Derived from this study: PubMed 34637497Kresovich JK, Park YM, Keller JA, Sandler DP, Taylor JA. Healthy eating patterns and epigenetic measures of biological age. Am J Clin Nutr. 2022 Jan 11;115(1):171-179. doi: 10.1093/ajcn/nqab307.
- Derived from this study: PubMed 30968114Petimar J, Park YM, Smith-Warner SA, Fung TT, Sandler DP. Dietary index scores and invasive breast cancer risk among women with a family history of breast cancer. Am J Clin Nutr. 2019 May 1;109(5):1393-1401. doi: 10.1093/ajcn/nqy392.
- Sister Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00047970, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.