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临床试验/NCT06410729
NCT06410729已完成不适用

Significance of Benign Lymph Node Enlargement in Colorectal Cancer

Peking University Third Hospital0 个研究点目标入组 2,270 人开始时间: 2015年1月1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
2,270
主要终点
Disease-free survival of participants

研究概览

简要总结

The objective of this observational study was to investigate the clinical significance of benign mesenteric lymph node (BLNE) enlargement in patients with colorectal cancer. The main questions it aims to answer are:

Do patients with benign mesenteric lymph node enlargement have a better prognosis? What are the clinical characteristics of benign mesenteric lymph node enlargement? As part of routine medical care for colorectal cancer, we will follow up with all participants over the course of the study.

详细描述

From January 2015 to June 2023, 2,270 patients with colorectal cancer received surgical treatment at Peking University Third Hospital. The clinical data of these patients were recorded retrospectively and the eligible patients were divided into two groups. According to the 9th edition of the TNM staging System published by the AJCC, the BLNE group included the mesenteric BLNE group, while the non-benign lymph node enlargement (NBLNE) group was the control group. Inclusion criteria were :1) No regional lymph node metastasis or distant metastasis; 2) Stage I and II patients with AJCC staging system; 3) Radical CRC resection reached R0 status, no positive lymph nodes; Colonoscopy confirmed a single malignant lesion. Exclusion criteria :1) emergency surgery or preoperative complications such as intestinal obstruction and perforation; 2) Positron emission tomography (PET-CT) suspected distant metastasis; 3) Preoperative neoadjuvant therapy; 4) Hereditary colorectal cancer such as familial adenomatous polyposis; Microsatellite instability (MSI) was confirmed by pathology. In early colorectal cancer, MSI-H status is associated with a favorable prognosis and enhanced anti-tumor immune response. Therefore, we excluded these patients to avoid their influence on prognosis. 6) Lack of imaging data; 7) Loss of follow-up.

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

入选标准

  • no regional lymph node metastasis or distant metastasis;
  • stage I and II patients in the AJCC staging system;
  • radical CRC resection achieving R0 status with no positive lymph nodes;
  • a single malignant lesion confirmed via colonoscopy

排除标准

  • underwent emergency surgery or had preoperative complications such as intestinal obstruction or perforation;
  • had suspected distant metastasis on positron emission tomography (PET-CT);
  • received preoperative neoadjuvant therapy;
  • had hereditary CRC such as familial adenomatous polyposis;
  • had microsatellite instability (MSI) confirmed by pathology.
  • lacked imaging data;
  • were lost to follow-up.

结局指标

主要结局

Disease-free survival of participants

时间窗: The time from the participants' first postoperative day to their last follow-up.

From the time participants started undergoing radical surgery until their tumors returned or they died from tumor causes. The unit is month.

次要结局

  • Overall survival of the participants(The time from the participants' first postoperative day to their last follow-up.)

研究者

申办方类型
Other
责任方
Sponsor

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