Status:
ACTIVE_NOT_RECRUITING
Study of Radiation Exposure and Bilateral Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Translational Genomics Research Institute
University of Southern California
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-54 years
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, trea...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
1699 Patients enrolled
Trial Details
Trial ID
NCT00903591
Start Date
May 1 2009
End Date
May 1 2026
Last Update
June 3 2025
Active Locations (6)
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1
Stanford University
Stanford, California, United States, 94305
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109