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

NCT07380464 | Completed

• 1 other identifier: 2025ZSLYEC-785
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Colon Cancer; Tumor Deposits; Lymph Node Metastases; TNM Staging

Keywords

Colon Cancer; Lymph Node Metastases; N stage

Outcome Measures

Primary Outcomes (2)

• DFS

  Disease Free Survival

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

• OS

  Overall Survival

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

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolled a total of 1,500 participants between January 2010 and December 2022. Inclusion criteria were defined as follows: (1) a confirmed diagnosis of primary colon adenocarcinoma via auxiliary examination or pathology; (2) absence of distant metastasis (M0) verified by preoperative imaging or intraoperative findings; (3) initial radical colectomy; and (4) complete documentation of lymph node counts across three stations. Patients were excluded if they had received any form of neoadjuvant therapy (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy) prior to surgery. Additionally, cases were excluded if intraoperative or postoperative pathology revealed non-malignant tumors (including carcinoma in Tis) or if patients presented with multiple primary cancers or concurrent malignancies in other sites.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cai Zerong: lead

MeSH Terms

Conditions

Colonic Neoplasms; Extranodal Extension; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zerong Cai, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of the Department

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 2, 2026
• Study Start: March 5, 2010
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share