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

January 28, 2026 updated by: Cai Zerong

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months
OS
Time Frame: From the date of the initial surgery to death, assessed up to 120 months
Overall Survival
From the date of the initial surgery to death, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cai Zerong

Investigators

  • Study Director: Zerong Cai, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2010

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025ZSLYEC-785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Please contact us by Email.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colon Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe