Study of Radiation Exposure and Bilateral Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: questionaire, blood or saliva sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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. | Other: questionaire, blood or saliva sample<br>* Take part in an approximately 45 minute telephone interview, with questions about detailed treatment (chemotherapy, hormonal therapy, radiation therapy (RT)) for all study participants. Their medical records will be reviewed to get further details about treatment of their breast cancer. They donate either a 35 ml blood sample (about 3 tablespoons) or a saliva sample. Blood Sample: if patient consents to give a blood sample, following the interview, they will be contacted by our staff phlebotomist (a person trained to draw blood). A scheduled appointment to draw a blood sample from you at your home. At the time of the blood draw, the phlebotomist will collect approximately 2 and 1/3 tablespoons of blood. Saliva Sample: if they choose not to give a blood sample, but consent to give a saliva sample instead, a saliva kit will be sent to there home. Once they provide the sample in the kit, they will be asked to mail back the sample in the pre-labeled kit that was sent to them.<br>* Other names: via mail or telephone.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, cancer, 09-040, blood sample, saliva sample, WECARE, GWA