Markers for Breast Cancer (NCT00339248) | Clinical Trial Compass
CompletedNot Applicable
Markers for Breast Cancer
United States2,632 participantsStarted 2004-12
Plain-language summary
This study will analyze blood samples to identify substances that are associated with the development of breast cancer. It will determine if:
* Women who are diagnosed with a benign breast condition that is related to a considerably increased risk of breast cancer are more likely to have certain gene variants than women diagnosed with conditions related to very little increased breast cancer risk
* Women with benign breast conditions who subsequently develop breast cancer are more likely to have certain gene variants than women with similar benign conditions who do not develop breast cancer.
This study will examine blood samples from premenopausal women who underwent breast biopsy (removal of a small piece of breast tissue for microscopic examination) at four hospitals in Grand Rapids, MI, from 1977 to 1987 and were found to have benign breast disease. The women, who agreed to participate in a study of markers for breast cancer, also provided a blood sample and were interviewed for information on their breast cancer risk factors, family history of breast cancer, use of medications, and history of medical conditions.
This study will retrieve the biopsy reports for these women, determine which of them later developed breast cancer, and perform genotyping on their blood samples.
The information from this study may help in future diagnosis and treatment of breast cancer.
Who can participate
Age range
15 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/EXCLUSION CRITERIA:
Potentially eligible premenopausal women include 2636 who did not have a previous or concurrent (within 60 days) diagnosis of breast cancer at the time of initial benign breast biopsy (study entry) and who have at least 4 mls of serum stored in the Frederick biorepository.
Of those 2636, four women have a code indicating "refused study" in the "follow-up" variable, and despite evidence of their consent to the original study, will be omitted from all future use of study data or specimens.
Participants also will be required to be Caucasian or African American (2599 or 98.6%), and to have a pathology report successfully retrieved from a participating hospital for review.
All sample sizes subsequently cited in the text take these inclusion criteria into account, and those cited for objective 2 also incorporate adjustment for loss to follow-up.
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.