Purpose of Study
The purpose of the "Breast Imaging Study in Women at High Genetic
Risk of Breast Cancer" (NCI Protocol Number 01-C-0009)
is to:
- Evaluate the newest breast screening procedures to see if they are effective
in finding cancer early, especially in younger women
- Develop new tools to assist in finding malignant or pre-malignant
changes in breast cells, before cancer can be detected clinically
- Examine how women live and cope with a high risk of breast and ovarian
cancer
The study focuses on women between the ages of 25
and 56, who have undergone genetic testing and have found that they
have an altered ("mutated") BReast CAncer 1 (BRCA1) or
BReast CAncer 2 (BRCA2) gene. These women are aware of their increased
genetic risk of breast cancer and, most likely, have had varying
degrees of interaction with a health care professional about their
increased risk and cancer surveillance options.
The study will explore various screening methods for early detection of breast
and ovarian cancer in these high-risk women. It will also try to determine if
breast tissue characteristics in women with these mutations differ from those
in women with a normal gene.
Screening methods include:
- routine clinical examination of the breasts and ovaries
- mammogram
- instruction in breast self-examination technique
- CA-125 blood test
- transvaginal ultrasound of the ovaries
- magnetic resonance imaging (MRI) of the breasts
- breast duct lavage and/or nipple aspiration
Study participants are seen annually at the NIH Clinical Center for four
years.
The study has reached its recruitment goal of 200 participants and is no longer
enrolling new participants.
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