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临床试验/NCT00032201
NCT00032201已完成不适用

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

National Cancer Institute (NCI)2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2002年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

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