Study of Radiation Exposure and Bilateral Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Other: questionaire, blood or saliva sample
- Registration Number
- NCT00903591
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
This study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the risk of breast cancer. It will use different processes to find genes that might increase the risk of breast cancer. The results of this study may help to develop better ways to detect, treat and prevent breast cancer. This study will compare women who have breast cancer in both breasts to women who have breast cancer in only one breast.
- Detailed Description
This study expands upon an existing case-control study we call the Women's Environment Cancer and Radiation Epidemiology (WECARE) Study. For simplicity, in this protocol, we will refer to that study as the "parent" study. The goal of both studies is to examine the interaction of radiation exposure and genetic susceptibility factors in the etiology of breast cancer. A subset of study participants who consented to 'future contact' in the GWA Study (and those in the 'parent' study from selected sites) will be included in an analysis of radiation-related heart disease and related conditions.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1699
- Eligibility for Cases: All women who meet the following eligibility requirements will be recruited as cases for the WECARE:GWA Study if they are not already cases (or refusers) from the parent WECARE Study:
- Diagnosed since 1/1/1990 with a histologically confirmed first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (cancer registry);
- Diagnosed since 1/1/1992 with CBC (invasive only any stage) while residing in the same enrollment site (cancer registry);
- Two years or longer time interval between first and second primaries; Between the ages of 18 and 54 at the time of diagnosis of the first primary;
- Alive at time of contact; and
- No history of previous or intervening cancer diagnosis, except cervical cancer in situ (CIS) or non-melanoma skin cancer.
- Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.
Eligibility for Controls: Women who meet all of the following requirements will be eligible as controls. One matched control will be recruited for each participating case:
- Diagnosed since 1/1/1990 with their first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (i.e., cancer registry);
- Between the ages of 18 and 54 at the time of diagnosis of the first primary;
- Residing in the same study enrollment site (cancer registry) as when they were diagnosed with their breast cancer;
- Alive at time of contact;
- Never diagnosed (at reference date (date of first diagnosis plus "at risk interval" of matched case)) as having had CBC or any other cancer diagnosis other than the original breast cancer; with the exception of CIS or non-melanoma skin cancer.
- Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.
Matching of Controls: Controls eligible for inclusion in this study will be individually matched (1:1) to cases on:
- Enrollment site (cancer registry);
- Age at diagnosis of the cases first primary(within 5-year age groups);
- Year of diagnosis of the cases first primary;(within 4-year categories);
- Race/ethnicity (white, black, Latina, Asian, other).
Exclusion for Cases: Women with any of the following characteristics will be ineligible as a case:
- Unable to speak English in U.S. or Canadian enrolling sites or Spanish in the California site, and Danish in Denmark
- Unable to sign informed consent
- Stage IV distant metastases for either the first or second primary (lymph node metastasis is acceptable, but there should be no organ involvement
- Simultaneous diagnosis of invasive in one breast and in situ in the other breast
Exclusion for Controls: Women with any of the following characteristics will be ineligible as a control:
- Unable to speak English in U.S. and Canadian enrolling sites, or Spanish in the California site and Danish in Demark
- Unable to sign informed consent
- Stage IV distant metastases (lymph node metastasis is acceptable, but there should be no organ involvement
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 questionaire, blood or saliva sample All women will be interviewed by telephone using the a similar questionnaire as used in the parent study. DNA samples will be obtained either via blood samples drawn during a home or clinic visits, or an Oragene Saliva DNA Self-Collection Kit sent to the participant's home.
- Primary Outcome Measures
Name Time Method Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study. 2.5 years
- Secondary Outcome Measures
Name Time Method Identify single nucleotide polymorphism that interact with radiation exposure. 2.5 years Replication. Using the entire WECARE Study population, determine whether genomic regions found to be associated with unilateral breast cancer as identified via independent genome-wide association studies conducted by other research groups. 2.5 years Characterize genomic regions containing variants associated with contralateral breast cancer and/or radiation-induced breast cancer in a population-based nested case-control study design. 2.5 years
Trial Locations
- Locations (6)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
ONTARIO CANCER REGISTRY, Mount Sinai Hospital, Toronto
🇨🇦Toronto, Ontario, Canada
Danish Cancer Society
🇩🇰København, Denmark
Stanford University
🇺🇸Stanford, California, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States