Susceptibility to Breast Cancer
|ClinicalTrials.gov Identifier: NCT00004565|
Recruitment Status : Completed
First Posted : February 14, 2000
Last Update Posted : April 19, 2018
This study will explore whether different forms, or variants, of genes are related to a person s risk of developing breast cancer. The genes that are looked at have no clinical significance today, and thus will not impact your personal healthcare at this time. However, these results may help researchers better understand why some people develop breast cancer and others do not. The study will try to determine:
if people with breast cancer have different gene variants from people without the disease;
if these genetic differences influence a person s susceptibility to breast cancer when they are exposed to certain environmental substances, such as nicotine and estrogen; and
if breast cancer that occurs in families is related to a grouping of these variants.
The study will also look for certain proteins, cells, or other substances in fluid aspirated (by the use of gentle suction; no needles) from the nipple that might represent a pattern, or "fingerprint," indicating increased risk for breast cancer.
Study participants will complete questionnaires on cancer risk factors, diet, and family history. A small blood sample (3 tablespoons) will be drawn for study of genetic differences between people with breast cancer and people who are cancer-free. Nipple aspirations, a noninvasive method to obtain fluid from a women s breast, will be attempted 4 to 6 times, over a 4 6 week period. For this procedure, the subject places a warm moist towel over the breasts for about 20 minutes. The breasts are then cleansed with a rubbing alcohol pad. The subject compresses the breast with both hands and a small plastic cup is inverted over the breast. Suction is applied to a small syringe (no needles) attached to the cup for about 15 seconds. The procedure may be repeated up to 5 times on each breast. Any drops of fluid obtained from the nipple will be collected in a glass tube.
|Condition or disease|
|Breast Cancer Healthy|
Cancer risk, even among those with similar environmental exposures is not uniformly distributed. Although we have been able to identify genetic factors whose variants appear to significantly alter an individual's risk of developing breast cancer (BRCA1 and BRCA2), these genes are likely involved with less than 10% of breast cancer cases. Perhaps more applicable to the general population are genes which, while not directly involved with the oncogenic process, may have variants (polymorphisms) which act indirectly by increasing the risk of an oncogenic change within a cell.
It is the goal of this proposal to look at genes, environment, clinical co-factors, and, if possible, any interactions in breast cancer. The ultimate objective of these studies is to establish an effective way of identifying individuals at greatest risk for cancer. We will evaluate the risk of breast cancer associated with polymorphisms in genes involved in estrogen metabolism and action. We will also evaluate the association of breast density and polymorphisms in genes associated with estrogen metabolism and action. In addition, we will also evaluate nipple aspirate fluid and breast duct lavage fluid as another potential source of promising biomarkers of risk.
|Study Type :||Observational|
|Actual Enrollment :||737 participants|
|Official Title:||Susceptibility to Breast Cancer|
|Study Start Date :||February 8, 2000|
|Study Completion Date :||May 4, 2012|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004565
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Giuseppe Giaccone, M.D.||National Cancer Institute (NCI)|