Research Study to Determine Relationship between Early Cellular Changes in the Breast and Near-Term Breast Health Using Ductal Lavage Procedure
Eleven medical centers nationally are participating in a five-year research study of women at high-risk for developing breast cancer. Physicians at leading hospitals across the country, including UCLA and Cedars-Sinai Medical Center, are among a select, national group of breast cancer specialists who will evaluate and monitor early cellular changes in the breast milk ducts of high-risk women using ductal lavage, a minimally-invasive procedure of collecting cells from the breast milk ducts - where more than 95 percent of breast cancers originate. The objective of the research study, called "SEDE" (Serial Evaluation of Ductal Epithelium), is to define the relationship between early cellular changes in the breast as identified by the ductal lavage procedure and near-term breast health. The results of the research study will establish the role that breast duct cell changes, as obtained by ductal lavage, plays in gauging a high-risk woman's individual risk for developing breast cancer.
Breast cancer is the leading cause of cancer in women in the United States. The National Cancer Institute (NCI) estimates that about one in eight women in the U.S. will develop breast cancer during her lifetime. Millions of women are at risk for developing the disease. At-risk women may be eligible to participate in the research study if they meet the following conditions:
- Are between the ages of 35-70
- Have a family history of breast cancer (multiple family members) or other known risk factors
- Have no personal history of breast cancer
Study participants will undergo ductal lavage every six months for three years in conjunction with a clinical breast exam every six months and a mammogram every twelve months. Physicians at both UCLA and Cedars-Sinai Medical Center will monitor participants' breast health for an additional two years. The ductal lavage procedure and ongoing physician monitoring is available free of charge to women who quality for the research study.
Additional centers involved include Baylor University Medical Center, Dana Farber and Massachusetts General Hospital, Indiana University, University of Alabama, University of Oklahoma, UT Southwestern, Magee-Womens Hospital and University of Connecticut. For more information about the SEDE research study in the Southern California area, please contact 1-888-KNOW-RISK (1-888-566-9747).
About the Ductal Lavage Procedure
Commercially available as the FirstCyte Breast Test, the ductal lavage procedure begins with the application of an anesthetic cream to the nipple to numb the area. Next, a small suction cup is used to help draw tiny amounts of ductal fluid up to the nipple surface, to determine the duct's natural opening. A tiny plastic tube is inserted into the ductal opening and an anesthetic is delivered to numb the inside of the duct, and then the duct is rinsed with a balanced electrolyte solution to collect cells. The cell specimen is then sent to a laboratory to determine whether the cells are normal or atypical. The devices used in the ductal lavage procedure are cleared by the U.S. Food and Drug Administration (FDA) for obtaining breast duct cells.