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临床试验/NCT06511661
NCT06511661进行中(未招募)不适用

Prognostic Significance of the Uncertain Resection Based on the Extent of Nodal Dissection for Non-small Cell Lung Cancer: A Propensity Score Matching Retrospective Study

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 3,783 人开始时间: 2024年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3,783
试验地点
1
主要终点
5-year disease-free survival

研究概览

简要总结

The concept of residual tumor classification proposed by the Union for International Cancer Control (UICC) was used to assess the completeness of surgical resection, and non-small cell lung cancer (NSCLC) patients with incomplete resection were more likely to occur recurrence, leading to significantly poor survival. But this R classification only refers to the surgical margin and neglects other factors associated with surgical quality, such as the extent of lymph node dissection (LND). Therefore, the International Association for the Study of Lung Cancer (IASLC) proposed the definition of uncertain resection [R(un)], which includes the suboptimal extent of LND. However, the clinical significance of R(un) is still controversial. On the one hand, some researches demonstrated that R(un) had definite prognostic significance, with R(un) survival stratifying between R0 and R1. On the other hand, some studies indicated that in early-stage NSCLC, the suboptimal extent of LND had no impact on survival, and the concept of R(un) might be insignificant in these patients. Even in those studies supporting the prognostic significance of R(un), which kind of patients is suitable for R(un) was still unclear. Thus, the investigators explore the impact of the R(un) on the long-term survival of patients with NSCLC using a large cohort in China, to identify those patients who could really benefit from the LND required by the R0 classification proposed by IASLC.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Primary non-small cell lung cancer
  • With pulmonary resection

排除标准

  • Sublobar resection
  • Positive highest mediastinal lymph nodes
  • Operative death

结局指标

主要结局

5-year disease-free survival

时间窗: 5 years after surgery

The disease-free survival rate 5 years after surgery

5-year overall survival

时间窗: 5 years after surgery

The overall survival rate 5 years after surgery

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mu-Zi Yang

Principal Investigator

Sun Yat-sen University

研究点 (1)

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