Study of Radiation Exposure and Bilateral Breast Cancer (NCT00903591) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study of Radiation Exposure and Bilateral Breast Cancer
United States, Canada, Denmark1,699 participantsStarted 2009-05
Plain-language 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.
Who can participate
Age range
18 Years – 54 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.