NCT00082979Unknown2 期
Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment.
PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast cancer.
详细描述
OBJECTIVES:
Primary
- Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1, BRCA2, or p53 gene mutations who have cellular atypia.
- Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy.
Secondary
- Determine patient acceptance of duct endoscopy.
- 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.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cellular atypia in nipple aspirate or ductal lavage fluid
- •Enrollment on RMNHS-2242 or RMNHS-2269 required
- •No inflammatory breast cancer
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal Status
- •Any status
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No prior allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
- •No severe illness that would preclude study participation
- •No mental illness or handicap that would preclude study compliance
- •No active infection or inflammation in the breast being studied
- •No nursing within the past 12 months
- •Not pregnant
- •Not unconscious
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No prior tamoxifen
- •Radiotherapy
- •Not specified
- •No prior subareolar surgery (e.g., papilloma resections, biopsies, or fine needle aspirations) or any other surgery that may disrupt the ductal systems within 2 cm of the nipple
- •Biopsies and fine needle aspirations > 2 cm from the nipple are allowed
- •No prior breast implantation on proposed lavage side
- •No prior chemopreventative agents
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy
Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy
Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling
Comparison of cell yields vs final surgical pathology
次要结局
未报告次要终点
研究者
研究点 (1)
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