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Home > "S" Clinical Trials Conditions > Sister Study  Sister Study
Sister Study
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): National Institute of Environmental Health Sciences (NIEHS) ,
Synopsis: 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.
Details: 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 will be recruited nationally through health professionals, breast cancer advocates, the Internet, and a national advertising campaign. Recruitment strategies will maximize inclusion of minorities and high-risk women. 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.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 35 Years/74 Years
Genders: Female
Protocol Entry Criteria: Women who are eligible for the Sister Study - Have a sister who had breast cancer - Age 35-74 - Never had breast cancer - Live in the United States The Sister Study is currently recruiting sisters of women diagnosed with breast cancer in ARIZONA, FLORIDA, MISSOURI and RHODE ISLAND. The study will open for national enrollment in Fall 2004.
Total Enrollment: 50000
Location and Contact Information:
NIEHS *Recruiting*
Research Triangle Park, North Carolina, 27514
United States
Recruiting Dale Sandler 919-541-4668
Additional Information:
Study ID Numbers: 02-E-N-271;
Study Start Date: August 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047970
Other Breast Cancer Studies:
1. Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
2. LY353381 in Preventing Breast Cancer in Women With Hyperplasia
3. Study of two doses of ALIMTA (pemetrexed) as first line chemotherapy for advanced breast cancer
4. Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
5. Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
Related Studies:
Other Breast Cancer Clinical Trials
Other North Carolina Clinical Trials
Other Research Triangle Park Clinical Trials
Sister Study
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