GeneSearch Breast Lymph Node (BLN) Assay Timing Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 233
- 试验地点
- 6
- 主要终点
- To collect data in relation to other surgical procedures during the SLND/breast surgery to determine if the assay TAT resulted in longer surgery time than would have occurred if the assay had not been used.
研究概览
简要总结
This study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.
详细描述
Assay turn-around-time will be collected at sites that are using the GeneSearch BLN Assay for intraoperative testing of sentinel lymph nodes. The sites must be planning to use the assay result to guide the decision to complete an axillary lymph node dissection.
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
- •Pre-operatively established diagnosis of invasive carcinoma of the breast
- •Scheduled for axillary sentinel lymph node dissection as per standard of care at the clinical site for newly diagnosed breast cancer patients
- •Patients for whom the GeneSearch™ BLN Assay will be used intra-operatively to make a decision for an axillary lymph node dissection
- •18 years of age or older
- •Female or male
排除标准
- •Previous diagnosis of lymphoma
- •Subjects participating in other research studies that would interfere with their full participation in this study
- •Patients and/or conditions with 'interfering substances' as listed in the IFU
- •Patients who have had any pre-operative treatment for breast cancer including neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen
结局指标
主要结局
To collect data in relation to other surgical procedures during the SLND/breast surgery to determine if the assay TAT resulted in longer surgery time than would have occurred if the assay had not been used.
时间窗: 1 day
To determine, under clinical use conditions, the assay turn-around-time (TAT) from the time of node removal to the report of the assay result to the surgeon.
时间窗: 1 day
To determine, under clinical use conditions, whether the assay result was or was not received in time ('time for decision' (TFD)) to make an intra-operative decision to proceed to further non-sentinel axillary lymph node dissection.
时间窗: 1 day
次要结局
未报告次要终点