NCT00083018Unknown2 期
Evaluation Of The Role Of Nipple Aspiration, Ductal Lavage And Duct Endoscopy At The Time Of Surgery In Patients With Breast Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment.
PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.
详细描述
OBJECTIVES:
Primary
- Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer.
- Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients.
Secondary
- Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients.
- Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients.
- Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients.
- Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 —（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
Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells
Comparison of cell yields vs final surgical pathology of the operative specimens
Correlation of cell yields and morphology in ductal lavage with duct endoscopy appearances and findings
次要结局
未报告次要终点
研究者
研究点 (2)
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