Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,699
- 试验地点
- 6
- 主要终点
- Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
1
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.
干预措施: questionaire, blood or saliva sample (Other)
结局指标
主要结局
Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.
时间窗: 2.5 years
次要结局
- 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)