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

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001496
• Other study ID #: 960026
• Secondary ID: 96-C-0026
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: January 1996
• Est. completion date: November 2001

Study information

• Verified date: November 2001
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Hereditary Neoplastic Syndrome
• Neoplasms
• Neoplastic Syndromes, Hereditary

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Miki Y, Swensen J, Shattuck-Eidens D, Futreal PA, Harshman K, Tavtigian S, Liu Q, Cochran C, Bennett LM, Ding W, et al. A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science. 1994 Oct 7;266(5182):66-71. — View Citation

Sgagias MK, Gagneton DC, Rosenberg SA, Danforth DN Jr. Cellular characterization and retroviral transduction of short-term breast cancer cells. J Immunother Emphasis Tumor Immunol. 1995 Feb;17(2):88-97. — View Citation

Wooster R, Neuhausen SL, Mangion J, Quirk Y, Ford D, Collins N, Nguyen K, Seal S, Tran T, Averill D, et al. Localization of a breast cancer susceptibility gene, BRCA2, to chromosome 13q12-13. Science. 1994 Sep 30;265(5181):2088-90. — View Citation