Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004565
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2000-02-11
Brief Title:
Susceptibility to Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Susceptibility to Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-05-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 individuals 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0079 | None | None | None |