Studying Normal Breast Tissue and Cancer Risk
Condition: Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases
MeSH terms: Neoplasms; Breast Neoplasms; Neoplasms by Site; Skin Diseases; Breast Diseases
Study type: Observational

Summary: 
      Breast cancer is the most common cancer among women in the United States. Breast cancer
      research has been hampered by the difficulty in collecting normal breast tissue. In this
      study, researchers will obtain samples of normal breast tissue from organ donors and will
      collect risk-factor data from next-of-kin.

      The purpose of this study is to learn how normal breast develops and responds to stresses
      that are known to increase a woman s chance of developing breast cancer.

      Following the breast-tissue donation from 20 volunteers, surgical technicians will make small
      incisions in the skin and tissue of the breast and remove several samples measuring about
      one-inch. Technicians also will take samples of the uterine lining to estimate the date of
      the last menstrual period. The tissue will then be sent to the National Cancer Institute for
      laboratory research studies. Steps will be taken to ensure that the identity of the
      participants remains confidential.
    

Detailed description: 
      This pilot project, funded by a Breast Cancer Faculty Infrastructure Award, would determine
      the feasibility of obtaining samples of normal breast tissue from organ donors and collecting
      risk factor data from next-of-kin. The underlying goal of this initiative is to determine the
      associations between stages of breast development, risk factors for breast cancer, and gene
      expression. The study investigators are members of DCEG, CCR and the Transplant Resource
      Center of Maryland (TRC), a non-profit organization certified by HCFA and the state that
      processes most organ and tissue donations in Maryland. Trained staff or social workers
      employed by TRC who routinely obtain consent for donation from next-of-kin will also obtain
      consent for this study. The existing consent form for organ or tissue donation also includes
      informed consent for donation of tissue for research. Following organ procurement from 20
      volunteers, trained surgical technicians employed by TRC who routinely assist
      intra-operatively, will sterilely remove tissue from each breast quadrant and split the
      samples; one portion will be embedded in OCT and snap frozen in liquid nitrogen and the other
      fixed in 10% buffered formalin. Samples of adipose tissue, blood, urine and endometrium (for
      menstrual dating) will also be obtained. MES in conjunction with SMH and BKV will assess the
      samples histopathologically and determine the quantity and quality of macromolecules (RNA,
      DNA, protein) contained within the tissues. Pending demonstration of the feasibility of this
      general approach, we will pursue additional funding for a larger study with optimized
      procedures. We have stopped recruiting patients.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Samples of normal breast tissue from organ donors for assessment of histology.@@@@@@
      
Keywords: Mammary; Development; Cancer; Risk; Genes