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

Cai Zerong

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT07380464

2025ZSLYEC-785

Details and patient eligibility

About

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).

Enrollment: 1,500 patients

Sex: All

Volunteers: No 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.

Trial design

1,500 participants in 4 patient groups

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