Studying Normal Breast Tissue and Cancer Risk
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Skin Cancer, Cancer, Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 11 - 120 |
| Updated: | 8/11/2018 |
| Start Date: | April 7, 2003 |
Pilot Study to Collect Normal Breast Tissue From Organ and Tissue Donors
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.
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.
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.
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.
- INCLUSION CRITERIA
The study will enroll girls or women aged 11 years or older.
EXCLUSION CRITERIA
Men are excluded.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
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