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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07380464

Enrollment

1500

Registered

2026-02-02

Start date

2010-03-05

Completion date

2025-07-31

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Colon Cancer, Lymph Node Metastases, N stage

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
DFS	From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months	Disease Free Survival
OS	From the date of the initial surgery to death, assessed up to 120 months	Overall Survival

Contacts

STUDY_DIRECTORZerong Cai, MD

Sixth Affiliated Hospital, Sun Yat-sen University

Outcome results