Breast Cancer Prevention by Inducing Apoptosis in DCIS Using Breast Ductal Lavage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage
研究概览
简要总结
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is evaluating cells collected through ductal lavage in women undergoing surgery for ductal carcinoma in situ or other breast cancer.
详细描述
OBJECTIVES:
- Determine the expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures.
- Determine whether down-regulation by genetic manipulation of the anti-apoptotic genes bcl-2 and/or bcl-xL, alone or in conjunction with physiological preventive doses of tamoxifen citrate, has the highest induction of PCD in primary DCIS cell cultures.
- Determine the expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage.
- Determine whether down-regulation by genetic manipulation of the anti-apoptotic genes bcl-2 and/or bcl-xL, alone or in conjunction with physiological preventive doses of tamoxifen citrate, has the highest induction of PCD in cells obtained by breast ductal lavage.
OUTLINE: Patients undergo breast lavage to collect primary epithelial cells for cytological analysis before a planned surgical procedure. Ductal carcinoma in situ (DCIS) tissue samples obtained from surgery are used to establish primary DCIS cell cultures. The DCIS cells and primary epithelial cells obtained by ductal lavage are analyzed for endogenous protein levels of bcl-2, bax, and bcl-xL, using western blotting and immunohistochemical staining, to determine the appropriate antisense oligonucleotide molecule that will be used to induce apoptosis. The DCIS cells and primary epithelial cells obtained by ductal lavage are treated with antisense oligonucleotides and/or a physiological chemopreventive dose of tamoxifen citrate to determine which will provide the highest induction of cell death. The effect of these treatments on protein expression is analyzed by western blotting and immunohistochemistry. The effect of these treatments on markers of programed cell death (PCD) (i.e., DNA fragmentation and caspase activation) is also analyzed. Changes in mRNA expression are analyzed using a PCR-based quantitation assay.
Results from the molecular marker assays are not provided to the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage
Expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures
Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in primary DCIS cell cultures
Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in cells obtained by breast ductal lavage
次要结局
未报告次要终点