Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer

Purpose:

Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Study summary:

Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Criteria:

Women at high risk for breast cancer, either because they are a member of a high risk breast or ovarian cancer family, or because of a carcinoma of the opposite breast. Normal mammogram within past 3 months. No suspicious breast or axillary lesions on physical examination. No major cardiopulmonary, hepatic or renal disorders.

Study is Available At:

Original ID:

960026

NCT ID:

NCT00001496

Secondary ID:

96-C-0026

Study Acronym:

Brief Title:

Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer

Official Title:

Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer

ClinicalTrials.gov Link:

http://clinicaltrials.gov/show/NCT00001496

Overall Status:

Completed

Study Phase:

N/A

Genders:

Both

Minimum Age:

N/A

Maximum Age:

N/A

Study Source:

National Institutes of Health Clinical Center (CC)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:

Observational

Study Design:

N/A

Number of Arms:

0

Number of Groups:

0

Total Enrollment:

50

Enrollment Type:

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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