NCT01140776终止不适用
OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prospectively assess the performance of the OSNA Breast Cancer System for the detection of SLN metastasis in subjects treated with neoadjuvant therapy prior to SLN biopsy by comparing results with standard histopathology evaluation.
研究概览
简要总结
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section Hematoxylin and Eosin (H&E) and Immuno-histochemistry (IHC) staining.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •18 years of age or older
- •Diagnosed pre-surgically with T1-T3 or T4 non-inflammatory breast cancer, clinically node positive or node negative upon clinical examination
- •Scheduled for SLN biopsy after receiving neoadjuvant hormonal or chemotherapy
- •Subjects (or the subjects' legal representatives) who have read, understood (to the best of their ability) and signed the informed consent form.
排除标准
- •Pregnant subjects, confirmed by interview with either subject or treating physician
- •Subjects previously diagnosed with other invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma
- •Participation in other neoadjuvant protocols specifically requiring SLN biopsy prior to administration of neoadjuvant chemotherapy or hormonal therapy
- •Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
结局指标
主要结局
Prospectively assess the performance of the OSNA Breast Cancer System for the detection of SLN metastasis in subjects treated with neoadjuvant therapy prior to SLN biopsy by comparing results with standard histopathology evaluation.
时间窗: 18 months
次要结局
- Compare performance of the OSNA Breast Cancer System to intraoperative frozen section methods (mandatory) and imprint cytology methods (optional) with standard histopathology results from permanent sections.(18 months)
- Correlate OSNA results and histology results with the status of non-sentinel lymph nodes.(18 months)
- Determine incidence of breast cancer recurrence in axillary lymph nodes and distant organs within 5 years in study subjects (Phase II).(18 months)
研究者
研究点 (2)
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