Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083733
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-05-29
Brief Title:
Genetic and Protein Profiling in Normal and Cancerous Breast Tissue
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Procurement of Normal Breast Tissue and Metastatic Breast Cancer Tissue for Molecular Profiling
Status:
COMPLETED
Status Verified Date:
2010-11-17
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 collect analyze and compare genes and proteins in normal breast tissue with those in various tissues from women with breast cancer to look for changes that are unique to breast cancer cells Information about these differences may lead to more effective breast cancer treatments with fewer side effects The study has the following objectives
To define the molecular genetic and protein profile of normal breast tissue from pre- and post-menopausal women of different ages and who have had varying numbers of children or no children and who are in different phases of the menstrual cycle
To define the molecular profile of primary breast tumors and tumors that have metastasized spread beyond the primary site
To characterize breast cancer stem cells and establish cell lines from the pleural fluid fluid around the lungs of women with metastatic breast cancer A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen
The following women may be eligible for this study
Women who are undergoing cosmetic breast surgery that requires removal of some breast tissue eg breast reduction surgery
Women 18 years of age or older who are undergoing a biopsy or other surgical procedure to sample or remove a known or suspected primary or metastatic breast tumor
Women 18 years of age or older who are undergoing pleurocentesis a procedure to remove fluid from around the lung that is suspected or known to be caused by spread of breast cancer
Participants undergo the required procedure eg surgery biopsy or pleurocentesis and provide information that may include the following
Age raceethnicity
Age at first menstrual period menarche
Age at first pregnancy and age when the first child was born
Age at menopause
Information about primary breast cancer
Family history of breast cancer
Information on previous breast biopsies if any and hormones taken birth control pills or hormone replacement therapy if any
Copy of pathology report from procedure surgery biopsy or pleurocentesis
To define the molecular genetic and protein profile of normal breast tissue from pre- and post-menopausal women of different ages and who have had varying numbers of children or no children and who are in different phases of the menstrual cycle
To define the molecular profile of primary breast tumors and tumors that have metastasized spread beyond the primary site
To characterize breast cancer stem cells and establish cell lines from the pleural fluid fluid around the lungs of women with metastatic breast cancer A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen
The following women may be eligible for this study
Women who are undergoing cosmetic breast surgery that requires removal of some breast tissue eg breast reduction surgery
Women 18 years of age or older who are undergoing a biopsy or other surgical procedure to sample or remove a known or suspected primary or metastatic breast tumor
Women 18 years of age or older who are undergoing pleurocentesis a procedure to remove fluid from around the lung that is suspected or known to be caused by spread of breast cancer
Participants undergo the required procedure eg surgery biopsy or pleurocentesis and provide information that may include the following
Age raceethnicity
Age at first menstrual period menarche
Age at first pregnancy and age when the first child was born
Age at menopause
Information about primary breast cancer
Family history of breast cancer
Information on previous breast biopsies if any and hormones taken birth control pills or hormone replacement therapy if any
Copy of pathology report from procedure surgery biopsy or pleurocentesis
Detailed Description:
Background Defining the molecular profile gene and protein expression of normal breast tissue is essential to identifying markers for cellular subtypes in the normal human breast These markers could serve as biomarkers for prevention trials or represent new therapeutic targets if they are also expressed in early breast cancers The gene and protein expression in normal breast tissue may be dependent on the stage of the menstrual cycle whether the woman is pre- or post-menopausal prior pregnancy and breast feeding history and age The molecular profile of metastatic breast tumors may differ from that of the primary tumor and differ in metastases from different anatomic sites Identification of genesproteins unique to these lesions may help identify the processes responsible for metastatic spread at a molecular level and lead to the development of new molecularly targeted drugs Similarly isolation and characterization of breast cancer stem cells could provide new approaches for the treatment and prevention of breast cancer
Objectives To define the molecular profile of normal breast tissue from pre- and post-menopausal women of varying age and parity nulliparous to multiparous and in different phases of the menstrual cycle to study the molecular profile of primary and metastatic breast cancer lesions and to identify and characterize breast cancer stem cells and establish cell lines from the pleural fluid of women with breast cancer and malignant pleural effusions
Eligibility Women who are undergoing cosmetic breast surgery that entails resection of a portion of the breast eg reduction mammoplasty and who do not have a history of breast cancer women with known or suspected breast cancer who are having a primary tumor biopsied or resected or having a metastatic lesion biopsied or resected or women with breast cancer who are undergoing pleurocentesis for a suspected or known malignant pleural effusion
Design Normal breast tissues from cosmetic breast procedures that are performed in women without a history of breast cancer at Suburban Hospital will be snap frozen in liquid nitrogen and sent to the NCI for storage and analysis Demographic information will be collected from the women undergoing the procedure Similarly a portion of biopsies obtained from primary or metastatic lesions in women with suspected or known breast cancer at Suburban Hospital or the NIH will be collected after materials are obtained for diagnostic purposes snap frozen in liquid nitrogen and sent to the NCI with demographic information The unneeded fluid from pleurocenteses performed in women with breast cancer and malignant pleural effusions will be transported unfrozen to an NCI lab for immediate processing FAC sorting to isolate breast cancer stem cells RNA will be extracted from tissues and cDNA microarrays will be used to study gene expression Proteomic analysis of normal and malignant breast tissue will be studied using reverse-phase tissue lysates
Objectives To define the molecular profile of normal breast tissue from pre- and post-menopausal women of varying age and parity nulliparous to multiparous and in different phases of the menstrual cycle to study the molecular profile of primary and metastatic breast cancer lesions and to identify and characterize breast cancer stem cells and establish cell lines from the pleural fluid of women with breast cancer and malignant pleural effusions
Eligibility Women who are undergoing cosmetic breast surgery that entails resection of a portion of the breast eg reduction mammoplasty and who do not have a history of breast cancer women with known or suspected breast cancer who are having a primary tumor biopsied or resected or having a metastatic lesion biopsied or resected or women with breast cancer who are undergoing pleurocentesis for a suspected or known malignant pleural effusion
Design Normal breast tissues from cosmetic breast procedures that are performed in women without a history of breast cancer at Suburban Hospital will be snap frozen in liquid nitrogen and sent to the NCI for storage and analysis Demographic information will be collected from the women undergoing the procedure Similarly a portion of biopsies obtained from primary or metastatic lesions in women with suspected or known breast cancer at Suburban Hospital or the NIH will be collected after materials are obtained for diagnostic purposes snap frozen in liquid nitrogen and sent to the NCI with demographic information The unneeded fluid from pleurocenteses performed in women with breast cancer and malignant pleural effusions will be transported unfrozen to an NCI lab for immediate processing FAC sorting to isolate breast cancer stem cells RNA will be extracted from tissues and cDNA microarrays will be used to study gene expression Proteomic analysis of normal and malignant breast tissue will be studied using reverse-phase tissue lysates
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 |
|---|---|---|---|
| 04-C-0199 | None | None | None |