Trial Information

Pilot Study to Collect Normal Breast Tissue From Organ and Tissue Donors

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.