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

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).

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Extranodal Extension Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymph Node Metastases Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms TNM Staging Tumor Deposits

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Intraoperative or postoperative pathology confirming non-malignant tumors (including carcinoma in Tis).
Multiple primary cancers or concurrent malignancies in other sites.

Treatment and study plan

Primary outcomes

DFS

Time frame: From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months

Disease Free Survival
OS

Time frame: From the date of the initial surgery to death, assessed up to 120 months

Overall Survival

Sponsors and collaborators

Lead sponsor

Cai Zerong

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2025
Study completion: 2025
First posted: Feb 2, 2026
Registry last updated: Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed