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Protocol No. UW13061

Principal Investigator Wilke, Lee

Phase N/A

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Pilot Study: Comparison of rpFNA and CNB for Breast Tissue Collection for Chemopreventive Studies

Objective The purpose of the research is to test two standard techniques for breast biopsy to determine the best way to collect breast tissue for research studies. Scientists use breast tissue to learn more about breast biology, including how healthy breast tissue is different from breast cancer, and how these changes happen. It is useful for scientists to have enough breast tissue from each patient to be able to perform multiple studies at the same time. For example, in this study, the scientists will use the breast tissue to study the kinds of immune cells in the breast, as well as the inner structure of the breast. We think that both the immune system and breast structure can influence whether a woman is likely to develop breast cancer. If scientists can analyze a patients' tissue for several factors that give a woman a high risk for breast cancer, they can learn more about how these factors are interrelated. Understanding as much as possible about breast cancer is important for designing new preventive and treatment options. We will therefore compare two breast biopsy methods - Random Periareolar Fine Needle Aspiration (rpFNA) and Core Needle Biopsy (CNB) - to determine which method is better for collecting breast tissue for multiple studies in parallel.

Description If you decide to participate in this research you will be asked to allow the surgeons to perform the two types of biopsies to the breast during the operation described below. You will not be asked to do anything for the research study before or after the surgery. Both the rpFNA and the CNB procedures will be performed during your risk-reduction mastectomy or partial mastectomy, under anesthesia, in addition to a blood draw, also under anesthesia. Breast tissue will be sampled from the breast opposite to the cancer, in patients referred for partial mastectomy or from the breast undergoing removal for risk-reduction in the setting of a mastectomy.

Key Eligibility
  • Must be female, age 18 years or older
  • Eligible participants must have a planned bilateral or unilateral mastectomy for risk reduction or planned breast conservation surgery for unilateral breast malignancy (DCIS or invasive cancer)

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics