A New Classification System for Lymph Nodes in Colon Cancer: The Prognostic Significance of the Anatomical Distribution of Metastatic Lymph Nodes and the Number of Tumor Deposits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 主要终点
- DFS
研究概览
简要总结
This study aims to investigate the prognostic significance of LNM distribution and establish a new classification system integrating both nodal quantity and anatomical location.The main question it aims to answer is:
Does the new N staging based on lymph node metastasis patterns and cancer nodules provide a more accurate prediction of the prognosis of colon cancer patients compared to the AJCC N staging? The relevant clinical characteristics, treatment processes, postoperative pathological data and post-discharge prognosis information of the enrolled patients were collected through the follow-up offices and the medical record system. The data were analyzed. The main research endpoints were: overall survival (the time between the initial surgery and death or the last follow-up); disease-free survival (the time between the initial surgery and disease metastasis, recurrence or death).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of primary colon adenocarcinoma via auxiliary examination or pathology.
- •No distant metastasis (M0) confirmed by preoperative imaging or intraoperative findings.
- •No prior neoadjuvant therapy (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy).
- •Underwent initial radical resection for colon cancer.
- •Available data on lymph node counts for all three stations.
排除标准
- •Intraoperative or postoperative pathology confirming non-malignant tumors (including carcinoma in Tis).
- •Multiple primary cancers or concurrent malignancies in other sites.
研究组 & 干预措施
No metastasis
Non-skip metastasis without tumor deposits
No metastasis or non-skip metastasis with tumor deposits，Skip metastasis without tumor deposits
Skip metastasis with tumor deposits, All-station metastasis regardless of tumor deposits
结局指标
主要结局
DFS
时间窗: From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months
Disease Free Survival
OS
时间窗: From the date of the initial surgery to death, assessed up to 120 months
Overall Survival
次要结局
未报告次要终点
研究者
Cai Zerong
Deputy Director of the Department
Sixth Affiliated Hospital, Sun Yat-sen University