The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes
2014年6月16日 更新者:Tao OUYANG
Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient
- This is a phase II, prospective, single-center, non-randomized, non-controlled study.
- Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.
研究概览
研究类型
介入性
注册 (预期的)
200
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国、100142
- Breast cancer, Peking University Cancer Hospital & Institute
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
- abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm)
- ultrasound-guided FNA cytology of these nodes were performed
- the result of FNA cytology was negative (no tumour cell was found)
- patient planed to perform SLNB
Exclusion Criteria:
- pathological diagnosed ductal carcinoma in situ by excisional biospy
- abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
- the result of FNA cytology was positive (tumour cell was found)
- T4d tumour
- patient has recieved neo-adjuvant system therapy
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:negative FNA result of abnormal node
Axillary ultrasound examination was undergone for all breast cancer patients before sentinel lymph node biopsy (SLNB).
If abnormal axillary lymph node was found, ultrasound-guided FNA cytology of these nodes were performed.
The abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm.
Patients with negative results of FNA would undergo SLNB.
Technetium-99m-labeled Rituximab was used for lymphatic mapping.
Before the SLNB operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance.
In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.
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Before the sentinel lymph node biopsy (SLNB) operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance to localize the abnormal node.
In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
False negative rate of sentinel node biopsy if sonographic abnormal node not be removed
大体时间:one week after sentinel node biopsy
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one week after sentinel node biopsy
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Zhaoqing Fan, M.D.、Peking University Cancer Hospital & Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年5月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2013年12月4日
首先提交符合 QC 标准的
2013年12月4日
首次发布 (估计)
2013年12月9日
研究记录更新
最后更新发布 (估计)
2014年6月18日
上次提交的符合 QC 标准的更新
2014年6月16日
最后验证
2014年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.