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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


N/A
20 Years
80 Years
Not Enrolling
Female
Healthy

Thank you

Trial Information

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:

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.

Inclusion Criteria


- INCLUSION CRITERIA:

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.

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.

EXCLUSION CRITERIA:

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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

David N Danforth, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

020144

NCT ID:

NCT00032201

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Healthy
  • Surgery
  • Tissue Sample
  • Gene Expression Profiling
  • Tissue Array Gene Expression
  • Comparative Genomic Hybridization
  • Breast Cancer
  • Breast Cancer Risk
  • Breast
  • Breast Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000