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
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Sister Study: Genetic and Environmental Risk Factors for Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 50000
Study Start Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047970

Locations
United States, North Carolina
NIEHS
Research Triangle Park, North Carolina, United States, 27514
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

Responsible Party: Dale Sandler, Chief, Epidemiology Branch, DIR, National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00047970     History of Changes
Obsolete Identifiers: NCT00339820
Other Study ID Numbers: 02-E-N-271
Study First Received: October 23, 2002
Last Updated: November 5, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Breast Cancer
Sisters

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014