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临床试验/NCT07828925
NCT07828925已完成不适用

Selective Axillary Dissection After Neoadjuvant Chemotherapy in Patients With Lymphnode-positive Breast Cancer

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Number of patients where the lymph node containing the clip does not match the sentinel lymph node

研究概览

简要总结

The aim of this observational study is to collect data regarding the selective axillary dissection tecnique of lymphnode restaging after neoadjuvant chemotherapy in patients with Breast Cancer that is lymphonode positive at the time of the diagnosis.

研究设计

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

入排标准

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

入选标准

  • Age>= 18 years
  • Female sex
  • Diagnosis of Lymph Node- Positive (cN+) Breast Cancer through core needle biopsy, cT1-3 (multifocal too)
  • Absence of distant metastases (M0)
  • Patients that will undergo to NACT

排除标准

  • Previous diagnosis of Breast Cancer
  • Previous Breast and/or Axillary Surgery
  • Pregnancy
  • Inflammatory Breast Cancer (cT4)
  • Patients that will not undergo to NACT

结局指标

主要结局

Number of patients where the lymph node containing the clip does not match the sentinel lymph node

时间窗: From enrolment until Surgery Time

To verify the number Number of patients where the lymph node containing the clip does not match the sentinel

次要结局

  • Number of Patients that will not undergo to Selective Axillary Dissection(From enrolment until Surgery Time)
  • Number of preoperative correct identification of the lymph node with the clip(From enrolment until Surgery Time)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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