HealthyNCT00032201
Cell Lines From High-Risk Breast Tissue
An observational study of Healthy, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Healthy
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2002to 3 Dec 2014
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible, women must have one of the following:
- Women 20-80 years of age who have an increased risk of breast cancer because they are members of a high risk breast or ovarian cancer family. An Individual with a family history of verified breast and/or ovarian cancer is defined as including one of the following: 1) at least four cases of breast cancer. 2) Three cases of breast cancer and at least one case of ovarian cancer (two cases of ovarian cancer of which have to be first degree relatives). 3) Two cases of ovarian cancer in first degree relatives. High risk families may also include those with at least 4 cases of early onset (age less than 60) breast cancer or ovarian cancer (diagnosis at any age), or any family known to segregate a mutation in BRCA1 or another predisposing gene (i.e. BRCA2).
- Women with a history of ipsilateral 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 1.67 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 or equal to 5 years since completing radiation therapy.
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- Normal women not at increased risk of breast cancer (Gail model Index of less than 1.50%) 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 tissues.
Who cannot join
- Chemotherapy within 3 weeks prior to breast biopsy procedure.
- Pregnancy,
- White blood count less than 2000, platelet count less than 50,000.
- Concurrent infection.
- A history of bilateral whole breast radiation therapy.
- A suspicious unbiopsied lesion by physical examination or mammography of the breast(s) which is being studied.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20301
About this study
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
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.
Read more
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.
Read the 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 1.67 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 1.50 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.
- Conditions
- Healthy
- Keywords
- Surgery, Tissue Sample, Gene Expression Profiling, Tissue Array Gene Expression, Comparative Genomic Hybridization, Breast Cancer, Breast Cancer Risk, Breast
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2002 (estimated)
- Study start6 Mar 2002
- Study completion3 Dec 2014
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 HealthyStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David N Danforth, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032201
- Sponsor's protocol ID
- 020144
- Other IDs
- 02-C-0144
- Status last verified
- 3 Dec 2014
- First submitted
- 9 Mar 2002
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Henderson IC. Risk factors for breast cancer development. Cancer. 1993 Mar 15;71(6 Suppl):2127-40. doi: 10.1002/1097-0142(19930315)71:6+3.0.co;2-2. No abstract available.
PubMed 8443762Widschwendter M, Berger J, Daxenbichler G, Muller-Holzner E, Widschwendter A, Mayr A, Marth C, Zeimet AG. Loss of retinoic acid receptor beta expression in breast cancer and morphologically normal adjacent tissue but not in the normal breast tissue distant from the cancer. Cancer Res. 1997 Oct 1;57(19):4158-61.
PubMed 9331065Woodcock DM, Linsenmeyer ME, Doherty JP, Warren WD. DNA methylation in the promoter region of the p16 (CDKN2/MTS-1/INK4A) gene in human breast tumours. Br J Cancer. 1999 Jan;79(2):251-6. doi: 10.1038/sj.bjc.6690041.
PubMed 9888465
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00032201
- Acronym / sponsor ID
- 020144
- Conditions
- Healthy
- Keywords
- Surgery, Tissue Sample, Gene Expression Profiling, Tissue Array Gene Expression, Comparative Genomic Hybridization, Breast Cancer, Breast Cancer Risk, Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Mar 2002
- Study completion
- 3 Dec 2014
- First posted
- 11 Mar 2002 (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.
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.
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 1.67 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 1.50 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 design
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women 20-80 years of age who have an increased risk of breast cancer because they are members of a high risk breast or ovarian cancer family. An Individual with a family history of verified breast and/or ovarian cancer is defined as including one of the following: 1) at least four cases of breast cancer. 2) Three cases of breast cancer and at least one case of ovarian cancer (two cases of ovarian cancer of which have to be first degree relatives). 3) Two cases of ovarian cancer in first degree relatives. High risk families may also include those with at least 4 cases of early onset (age less than 60) breast cancer or ovarian cancer (diagnosis at any age), or any family known to segregate a mutation in BRCA1 or another predisposing gene (i.e. BRCA2).
- Women with a history of ipsilateral 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 1.67 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 or equal to 5 years since completing radiation therapy.
Key exclusion criteria (6 listed)
- Chemotherapy within 3 weeks prior to breast biopsy procedure.
- Pregnancy,
- White blood count less than 2000, platelet count less than 50,000.
- Concurrent infection.
- A history of bilateral whole breast radiation therapy.
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 17 Dec 2019.
- Background: PubMed 8443762Henderson IC. Risk factors for breast cancer development. Cancer. 1993 Mar 15;71(6 Suppl):2127-40. doi: 10.1002/1097-0142(19930315)71:6+3.0.co;2-2. No abstract available.
- Background: PubMed 9331065Widschwendter M, Berger J, Daxenbichler G, Muller-Holzner E, Widschwendter A, Mayr A, Marth C, Zeimet AG. Loss of retinoic acid receptor beta expression in breast cancer and morphologically normal adjacent tissue but not in the normal breast tissue distant from the cancer. Cancer Res. 1997 Oct 1;57(19):4158-61.
- Background: PubMed 9888465Woodcock DM, Linsenmeyer ME, Doherty JP, Warren WD. DNA methylation in the promoter region of the p16 (CDKN2/MTS-1/INK4A) gene in human breast tumours. Br J Cancer. 1999 Jan;79(2):251-6. doi: 10.1038/sj.bjc.6690041.
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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.
David N Danforth, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Cancer Institute (NCI) at 2 sites 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 9 inclusion and 6 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 NCT00032201, 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 17 Dec 2019; AzTrials last refreshed its copy on 30 Oct 2026.