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临床试验/NCT01622478
NCT01622478已完成不适用

Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients With Radiologically Positive Axillary Lymph Nodes

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1

研究概览

简要总结

Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower SLN identification rate and higher false negative rate. Further, the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to determine the identification rate, the false-negative rate, and the accuracy of SLNB after NAC for node positive breast cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Advanced breast cancer patients with node-positive proved in preoperative imaging study
  • ECOG status 0-1

排除标准

  • No previous cancer history
  • No previous chemotherapy history

研究组 & 干预措施

Clinically node-positive patients before NAC

Patients with clinically positive lymph node receiving neoadjuvant chemotherapy

  1. Clinically negative-node after NAC
  2. Clinically positive-node after NAC

干预措施: Sentinel lymph node biopsy (Procedure)

Clinically node-positive patients before NAC

Patients with clinically positive lymph node receiving neoadjuvant chemotherapy

  1. Clinically negative-node after NAC
  2. Clinically positive-node after NAC

干预措施: Neoadjuvant chemotherapy (Drug)

Clinically node-positive patients before NAC

Patients with clinically positive lymph node receiving neoadjuvant chemotherapy

  1. Clinically negative-node after NAC
  2. Clinically positive-node after NAC

干预措施: complete axillary lymph node dissection (Procedure)

Clinically node-positive patients before NAC

Patients with clinically positive lymph node receiving neoadjuvant chemotherapy

  1. Clinically negative-node after NAC
  2. Clinically positive-node after NAC

干预措施: positron emission tomography and ultrasonogram (Procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Gwe Ahn

Research Fellow, Breast Cancer Center

Gangnam Severance Hospital

研究点 (1)

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