Trial Information

Summary: Optical Biosensor for the Early Detection of Breast Cancer

You have been asked to participate in this research study either because you are undergoing routine breast cancer screening including screening mammography or because you are having a breast biopsy. The purpose of this study is to evaluate an investigational method for the detection of breast cancer. Your participation in this study is expected to last for two years. This may include the period before and after surgery if a breast biopsy is being performed. The study will continue to collect information from your medical charts or directly from you by telephone or letter for two years. We would like to determine if we could use a simple method to detect CEA or other proteins or patterns of proteins that may be present in the secretions from the nipple that will help in the early detection of breast cancer. Early detection is a major goal in the war against breast cancer. Mammography, clinical breast exams, and self-breast examination remain the major tools. Mammography can detect cancers as small as 1 mm3 (about the size of a pencil eraser), as long as the tumor is calcified; however, mammography does not always detect non-calcified tumors in patients with dense breasts or fibrocystic disease. Thus, approximately 20-25% of breast cancers (up to 50,000 patients per year) are not detected at an early stage. Sometimes the abnormalities that show up on mammography turn out not to be cancer. Approximately 55-85% of women who have a biopsy based on abnormal mammograms are found to have benign (non-cancerous) lesions.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 7, 2008 at 2:31:10 PM