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NCT07625735

MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastrointestinal Cancers

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

Lymph node metastasis (LNM) is a key factor influencing treatment decisions and prognosis in patients with gastric cancer. Lymphatic invasion (LI) is an important pathological predictor of LNM and a core component of the eCURA risk scoring system after endoscopic submucosal dissection (ESD) for early gastric cancer. However, whether LI has the same predictive value for LNM across different mismatch repair (MMR) statuses remains unclear. Compared with proficient mismatch repair (pMMR) gastric cancer, deficient mismatch repair (dMMR) gastric cancer has distinct molecular pathological features and an immune-enriched tumor microenvironment. In early gastric cancer, if LI is associated with a lower LNM risk in dMMR tumors than in pMMR tumors, existing LI-based eCURA risk assessment may overestimate LNM risk in patients with dMMR early gastric cancer and consequently affect decisions regarding additional surgery after ESD. Therefore, this study aims to systematically evaluate the association between MMR status, LI, and LNM using multi-center cohorts of patients with GC who underwent upfront gastrectomy or additional gastrectomy following ESD, and to explore the potential clinical value of incorporating MMR status into eCURA-based risk stratification for early GC. Furthermore, an independent colorectal cancer surgical cohort will be included to investigate whether these associations are consistent across different gastrointestinal malignancies.

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2026-11-01

Completion Date

2027-07-31

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

OTHER

Mismatch repair (MMR) status

Mismatch repair (MMR) status was assessed as part of routine pathological evaluation. Patients were classified as deficient mismatch repair (dMMR) or proficient mismatch repair (pMMR) according to immunohistochemical expression of MLH1, PMS2, MSH2, and MSH6.

OTHER

Lymphatic invasion status

Lymphatic invasion status was determined from routine pathological reports and classified as LI-positive or LI-negative.