Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032201
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2002-03-09
Brief Title:
Cell Lines From High-Risk Breast Tissue
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Establishment of Normal High Risk Breast Epithelial Cell Cultures and A High Risk Cell Line and Tissue Repository From Breast Tissue From Women at High Risk of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-12-03
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:
Background
Many risk factors for breast cancer have been identified including family history endocrine background changes in breast tissue cancer in one breast radiation exposure obesity and others There is a spectrum of tissue changes seen in cancerous and pre-cancerous breast tissue
A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen Cell lines developed from high-risk breast tissue allow researchers to perform metabolic and molecular studies of breast cells over time
Objective To establish a repository facility in which tissue samples can be preserved and stored for many years of cell lines from high-risk breast tissue to allow researchers to learn more about changes in breast cells that may cause them to develop into breast cancer
Eligibility Women between 20 and 80 years of age who
Have an increased risk of breast cancer because they are members of a high-risk breast or ovarian cancer family
Have had breast cancer in one or both breasts
Have had radiation for lymphoma before the age of 30
Have a mutation in a breast cancer susceptibility gene but whose family history is not known
Are not at increased risk of breast cancer
Design
A small piece of breast tissue will be obtained from about 10 women without an identified risk of breast cancer and up to 100 women at high risk of developing breast cancer
Cell lines will be developed from each high-risk category
The cell lines and tissues will be used to establish a repository of high-risk breast cell lines and breast tissues that can be used to study how the cells develop into breast cancer
Many risk factors for breast cancer have been identified including family history endocrine background changes in breast tissue cancer in one breast radiation exposure obesity and others There is a spectrum of tissue changes seen in cancerous and pre-cancerous breast tissue
A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen Cell lines developed from high-risk breast tissue allow researchers to perform metabolic and molecular studies of breast cells over time
Objective To establish a repository facility in which tissue samples can be preserved and stored for many years of cell lines from high-risk breast tissue to allow researchers to learn more about changes in breast cells that may cause them to develop into breast cancer
Eligibility Women between 20 and 80 years of age who
Have an increased risk of breast cancer because they are members of a high-risk breast or ovarian cancer family
Have had breast cancer in one or both breasts
Have had radiation for lymphoma before the age of 30
Have a mutation in a breast cancer susceptibility gene but whose family history is not known
Are not at increased risk of breast cancer
Design
A small piece of breast tissue will be obtained from about 10 women without an identified risk of breast cancer and up to 100 women at high risk of developing breast cancer
Cell lines will be developed from each high-risk category
The cell lines and tissues will be used to establish a repository of high-risk breast cell lines and breast tissues that can be used to study how the cells develop into breast cancer
Detailed Description:
Background
The NCI Surgery Branch
Multiple risk factors for breast cancer have been identified including family history endocrine background histologic changes in breast tissue cancer in one breast radiation exposure obesity and others The histologic phenotypes of breast carcinogenesis include a spectrum of changes beginning with normal appearing breast epithelium progressing to hyperplasia atypical hyperplasia in situ carcinoma and finally invasive carcinoma
Our present knowledge of high risk breast tissue is based on the study of a variety of cellular sample types which include fine needle aspirates nipple aspirate fluid core needle biopsies and breast tissue from mastectomy or segmentectomy specimens
Valid preclinical models are needed which utilize homogenous human cellular material which can be studied over time in large quantities
A model which may be ideally suited to the metabolic and molecular studies of breast epithelial cells is an in vitro cell line model developed from high risk breast tissue
In this study normal breast tissue will be acquired from each of the high risk sites for breast cancer in the breast These tissues will be used to develop breast epithelial cell lines for in vitro studies and to establish a high risk cell line and tissue repository
Objectives
To acquire normal breast tissue from each of the high risk sites for breast cancer in the breast
To develop breast epithelial cell lines from the normal high risk breast tissue from each of the major high risk sites
To establish a repository of high risk breast epithelial cell lines and high risk normal breast tissue which can be used as a resource for pilot studies at NIH and other participating centers to characterize high risk breast epithelial cells
Eligibility
Women age 20 - 80 years who have an increased risk of breast cancer because they are members of a high risk breast or ovarian cancer family
Women with a history of ipselateral breast cancer either invasive or in situ and a normal contralateral breast by mammography within the past 12 months and a normal physical examination of the contralateral breast and adjacent lymph node bearing areas or be undergoing prophylactic mastectomy
Women without breast cancer but with a Gail model estimate of 5-year risk of breast cancer of 167 percent or higher
Women with bilateral breast cancer invasive or in situ who have not received whole breast irradiation to both breasts
Women with a previous history of mediastinal irradiation for lymphoma before the age of 30 and who are now greater than 5 years since completing radiation therapy
Normal women not at increased risk of breast cancer Gail model Index of less than 150 percent and without abnormal findings in the breast by physical examination and mammography to serve as normal control tissue
Women with a mutation in a breast cancer susceptibility gene but whose family history is not known
Absence of significant cardiac hepatic or renal disease which in the opinion of the PI is likely to cause metabolic changes in the breast tissue
Design
A tissue acquisition in which Normal breast tissue will be collected from women at high risk of breast cancer at NIH and at other institutions as well Centers collecting tissue for this protocol must have IRB approval for this study and an IRB approved Informed Consent
All breast tissue will be obtained from surgical specimens acquired as part of planned surgical procedures Short-term cell lines will be developed from this tissue and confirmed cytologically and by expression of cytokeratins Multiple cell lines from each of the high risk categories will be developed
These cell lines and the respective tissues will be used to establish a repository of high risk breast epithelial cell lines and high risk breast tissues which can be used to further define the carinogenic pathway for breast cancer Early passages of these cell cultures and the respective normal breast tissue will be stored for future studies
100 patients will be enrolled over a period of 5 years
The NCI Surgery Branch
Multiple risk factors for breast cancer have been identified including family history endocrine background histologic changes in breast tissue cancer in one breast radiation exposure obesity and others The histologic phenotypes of breast carcinogenesis include a spectrum of changes beginning with normal appearing breast epithelium progressing to hyperplasia atypical hyperplasia in situ carcinoma and finally invasive carcinoma
Our present knowledge of high risk breast tissue is based on the study of a variety of cellular sample types which include fine needle aspirates nipple aspirate fluid core needle biopsies and breast tissue from mastectomy or segmentectomy specimens
Valid preclinical models are needed which utilize homogenous human cellular material which can be studied over time in large quantities
A model which may be ideally suited to the metabolic and molecular studies of breast epithelial cells is an in vitro cell line model developed from high risk breast tissue
In this study normal breast tissue will be acquired from each of the high risk sites for breast cancer in the breast These tissues will be used to develop breast epithelial cell lines for in vitro studies and to establish a high risk cell line and tissue repository
Objectives
To acquire normal breast tissue from each of the high risk sites for breast cancer in the breast
To develop breast epithelial cell lines from the normal high risk breast tissue from each of the major high risk sites
To establish a repository of high risk breast epithelial cell lines and high risk normal breast tissue which can be used as a resource for pilot studies at NIH and other participating centers to characterize high risk breast epithelial cells
Eligibility
Women age 20 - 80 years who have an increased risk of breast cancer because they are members of a high risk breast or ovarian cancer family
Women with a history of ipselateral breast cancer either invasive or in situ and a normal contralateral breast by mammography within the past 12 months and a normal physical examination of the contralateral breast and adjacent lymph node bearing areas or be undergoing prophylactic mastectomy
Women without breast cancer but with a Gail model estimate of 5-year risk of breast cancer of 167 percent or higher
Women with bilateral breast cancer invasive or in situ who have not received whole breast irradiation to both breasts
Women with a previous history of mediastinal irradiation for lymphoma before the age of 30 and who are now greater than 5 years since completing radiation therapy
Normal women not at increased risk of breast cancer Gail model Index of less than 150 percent and without abnormal findings in the breast by physical examination and mammography to serve as normal control tissue
Women with a mutation in a breast cancer susceptibility gene but whose family history is not known
Absence of significant cardiac hepatic or renal disease which in the opinion of the PI is likely to cause metabolic changes in the breast tissue
Design
A tissue acquisition in which Normal breast tissue will be collected from women at high risk of breast cancer at NIH and at other institutions as well Centers collecting tissue for this protocol must have IRB approval for this study and an IRB approved Informed Consent
All breast tissue will be obtained from surgical specimens acquired as part of planned surgical procedures Short-term cell lines will be developed from this tissue and confirmed cytologically and by expression of cytokeratins Multiple cell lines from each of the high risk categories will be developed
These cell lines and the respective tissues will be used to establish a repository of high risk breast epithelial cell lines and high risk breast tissues which can be used to further define the carinogenic pathway for breast cancer Early passages of these cell cultures and the respective normal breast tissue will be stored for future studies
100 patients will be enrolled over a period of 5 years
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 |
|---|---|---|---|
| 02-C-0144 | None | None | None |