一项比较 GeneSearch 乳腺淋巴结（BLN）检测试剂盒和永久病理切片检测乳腺癌患者腋窝前哨淋巴结转移的前瞻性、多中心临床试验 A Prospective and Multi-center Clinical Trial By Comparing GeneSearch™ Breast Lymph Node (BLN) Test Kit To Permanent Pathological Section On Detecting Axillary Sentinel Lymph Node Metastases In Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 540
- 试验地点
- 6
- 主要终点
- To compare GeneSearch™ BLN Test Kit to permanent pathological section to evaluate the clinical sensitivity and specificity of GeneSearch™ BLN Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.
研究概览
简要总结
The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.
The secondary objective of this trial is to evaluate the positive predictive value and negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.
Prospective and multi-center clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Diagnosed previously as breast cancer
- •patient scheduled for sentinel lymph node dissection
- •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, or
- •Prior sentinel or partial axillary lymphadenectomy on the same body side
研究组 & 干预措施
GeneSearch BLN Assay
Half of each sentinal lymph node will have GeneSearch BLN testing.
干预措施: GeneSearch™ Breast Lymph Node (BLN) Assay (Procedure)
Routine pathologic method
Half of each sentinal lymph node will have rountine pathologic examination as normal practice.
结局指标
主要结局
To compare GeneSearch™ BLN Test Kit to permanent pathological section to evaluate the clinical sensitivity and specificity of GeneSearch™ BLN Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.
时间窗: 9 months
次要结局
- To evaluate the positive predictive value and negative predictive value of GeneSearch™ BLN Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.(9 months)