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Home > "S" Clinical Trials Conditions > Susceptibility to Breast Cancer  Susceptibility to Breast Cancer
Susceptibility to Breast Cancer
For Condition: Healthy,Breast Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Case Populations: Individuals with breast cancer are being ascertained from among the patient population at National Naval Medical Center (NNMC) as well as other referring institutions. Individuals from the Clinical Center may also be eligible. There will be three groups of participants, which include a control group, individuals with a documented history of breast cancer, and individuals identified to be at high risk of developing breast cancer. Individuals with a documented history of breast cancer. Control Populations: The control participants have been ascertained from among the low risk screening population, and from non-cancer clinics and practices of the NNMC. Individuals with no prior history of any malignancy excluding skin cancers (except melanoma) and cervical cancer in situ. High Risk Population: Individuals that have been found to be at high risk for the development of breast cancer based on at least one of the following criteria: 1. Gail Model - an estimated risk of greater than 1.66 of developing breast cancer over the next five years. 2. Family History - history consistent with a hereditary breast or breast/ovarian syndrome. 3. History of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS). EXCLUSION CRITERIA: Inability to give informed consent. Individuals with any active infection or superficial inflammation of the breast, or who are currently lactating or who are less than 6 months post-lactation will not be eligible to undergo nipple fluid sampling, however they may still participate in the rest of the study.
Total Enrollment: 750
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Sheila Prindiville 3014960901
Additional Information:
Study ID Numbers: 000079; 00-C-0079
Study Start Date: February 8, 2000
Record last reviewed: January 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004565
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Susceptibility to Breast Cancer
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