GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.
研究概览
简要总结
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
详细描述
This study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the GeneSearch™ BLN Assay in patient samples by comparing its performance to that of the current methods -- permanent section Hematoxylin and Eosin (H&E) staining with IHC. Additional marker testing using probes associated with nodal metastases may be used in the assay performance calculations. The observed performance measures will be compared to those obtained in the larger U.S. registration trial to show that there are no differences in the assay's performance.
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
- •Previous diagnosis of carcinoma of the breast
- •Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
- •18 years or older
- •Female or male, and
- •Able and willing to give consent to participate in the study
排除标准
- •Patients taking part in other research studies that would interfere with their full participation in this study
结局指标
主要结局
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.
时间窗: 1 month
次要结局
- A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.(1 day)