Breast NeoplasmsNCT00083733
Genetic and Protein Profiling in Normal and Cancerous Breast Tissue
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2004to 17 Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects of any age who are undergoing cosmetic breast surgery that entails resection of breast tissue (e.g., reduction mammoplasty) for any reason.
- Women (18 years of age or older) with known or suspected breast cancer who are undergoing a diagnostic biopsy or resection of a primary breast lesions or a site of metastatic tumor.
- Women (18 years of age or older) with breast cancer who are undergoing a pleurocentesis for removal of fluid from a known or suspected malignant pleural effusion.
- All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their understanding that the specimens collected and demographic information provided is only for research purposes. Written assent will be obtained from pediatric patients (less than 18 years of age).
Who cannot join
- 1. Subjects who are undergoing cosmetic breast procedures such as reduction mammoplasty (collection of normal breast tissue) are excluded if they have a prior history of breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Procurement of Normal Breast Tissue and Metastatic Breast Cancer Tissue for Molecular Profiling
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.)
Read more
The following women may be eligible for this study:
- Women who are undergoing cosmetic breast surgery that requires removal of some breast tissue (e.g., 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 (e.g., surgery, biopsy, or pleurocentesis) and provide information that may include the following:
- Age, race/ethnicity
- 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)
Read the 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 genes/proteins 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 (e.g., 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.
- Conditions
- Breast Neoplasms
- Keywords
- Gene Expression, Microarray, Stem Cell, Proteomics, Metastases, Breast Tissue, Normal Breast Tissue, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2004 (estimated)
- Study start27 May 2004
- Study completion17 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083733
- Sponsor's protocol ID
- 040199
- Other IDs
- 04-C-0199
- Status last verified
- 17 Nov 2010
- First submitted
- 29 May 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Russo J, Rivera R, Russo IH. Influence of age and parity on the development of the human breast. Breast Cancer Res Treat. 1992;23(3):211-8. doi: 10.1007/BF01833517.
PubMed 1463860Russo J, Ao X, Grill C, Russo IH. Pattern of distribution of cells positive for estrogen receptor alpha and progesterone receptor in relation to proliferating cells in the mammary gland. Breast Cancer Res Treat. 1999 Feb;53(3):217-27. doi: 10.1023/a:1006186719322.
PubMed 10369068Hovey RC, Trott JF, Vonderhaar BK. Establishing a framework for the functional mammary gland: from endocrinology to morphology. J Mammary Gland Biol Neoplasia. 2002 Jan;7(1):17-38. doi: 10.1023/a:1015766322258.
PubMed 12160083
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procurement of Normal Breast Tissue and Metastatic Breast Cancer Tissue for Molecular Profiling
- ClinicalTrials.gov ID
- NCT00083733
- Acronym / sponsor ID
- 040199
- Conditions
- Breast Neoplasms
- Keywords
- Gene Expression, Microarray, Stem Cell, Proteomics, Metastases, Breast Tissue, Normal Breast Tissue, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 May 2004
- Study completion
- 17 Nov 2010
- First posted
- 31 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (e.g., 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 (e.g., surgery, biopsy, or pleurocentesis) and provide information that may include the following:
- Age, race/ethnicity
- 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 genes/proteins 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 (e.g., 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 design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (1 listed)
- 1. Subjects who are undergoing cosmetic breast procedures such as reduction mammoplasty (collection of normal breast tissue) are excluded if they have a prior history of breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1463860Russo J, Rivera R, Russo IH. Influence of age and parity on the development of the human breast. Breast Cancer Res Treat. 1992;23(3):211-8. doi: 10.1007/BF01833517.
- Background: PubMed 10369068Russo J, Ao X, Grill C, Russo IH. Pattern of distribution of cells positive for estrogen receptor alpha and progesterone receptor in relation to proliferating cells in the mammary gland. Breast Cancer Res Treat. 1999 Feb;53(3):217-27. doi: 10.1023/a:1006186719322.
- Background: PubMed 12160083Hovey RC, Trott JF, Vonderhaar BK. Establishing a framework for the functional mammary gland: from endocrinology to morphology. J Mammary Gland Biol Neoplasia. 2002 Jan;7(1):17-38. doi: 10.1023/a:1015766322258.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00083733, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.