What’s the study about?
The purpose of the study is to learn whether bacteria or viruses are present in ductal fluid. Ductal fluid from a woman’s breast ducts will be collected by nipple aspiration. The fluid will be analyzed to see if it contains any viruses or bacteria. The researchers will also identify differences in the fluid of women who have had breast cancer and women who have not that may provide new insights into the cause of breast cancer. The researchers will enroll up to 100 women for this study.
If you sign up for the Bacterial and Viral Diversity Study, you will be contacted by phone to confirm your eligibility. If you are eligible, the informed consent document will be sent to you. If you choose to participate, you will be asked to go to the Dr. Susan Love Research Foundation in Santa Monica for an appointment that will last approximately 90 minutes. On your appointment day, you will answer a brief questionnaire and ductal fluid will be collected from your breast. For the NAF (nipple aspirate fluid) collection procedure, your breast will be warmed with a heated pillow and massaged. A device similar to a breast pump will be placed over the nipple and a small amount of suction applied to obtain fluid from the ducts. You will be called 24 hours after the procedure and again 2 weeks after the procedure to see if you are experiencing any side effects.
Who is conducting the study?
Susan M. Love, MD, MBA, and Karen Duvall, MD, MPH, at the Dr. Susan Love Research Foundation in Santa Monica, California, and Delphine J. Lee, MD, PhD, at the John Wayne Cancer Institute, Santa Monica, California
Dr. Susan Love Research Foundation, Santa Monica, California
Who can participate?
You can join the Bacterial and Viral Diversity Study if you match ALL of these MAIN categories:
• You are a woman over the age of 18
• You have at least one intact nipple
• You have not been diagnosed with Stage IV, metastatic breast cancer
• You have not taken any antibiotic medication within the last 6 months
• You have not taken any oral contraceptives (birth control pills) or any form of estrogen in the last 12 months
• You are not currently lactating or have not lactated within the last 12 months
• You have not received chemotherapy or radiation therapy within the last 12 months
• You have not taken selective estrogen receptor modulators (SERMs) such as Tamoxifen or Raloxifene (Evista) OR aromatase inhibitors within the last 12 months
• You are willing to go to the Dr. Susan Love Research Foundation in Santa Monica, California, to participate in the study.
After you RSVP, the research team will ask you additional questions to be sure that this study is a good fit for you.