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Not yet recruiting NCT07625735

MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer

— Observational Gastric / Gastroesophageal Junction Adenocarcinoma Mismatch Repair Deficient or MSI-High Solid Tumors Lymph Node Metastasis Lymphatic Invasion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mismatch repair (MMR) status, Lymphatic invasion status.
Who it may be relevant to
Registry conditions: Gastric / Gastroesophageal Junction Adenocarcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Lymph Node Metastasis, Lymphatic Invasion. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Mismatch Repair (MMR) Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer

Overview

Brief 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 impact of MMR status on the association between LI and LNM using upfront-surgery and post-ESD additional-surgery cohorts from our center, and to explore the potential clinical value of MMR status in refining eCURA-based risk stratification for early gastric cancer.

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.

Primary outcome measures

  • Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients [Time frame: At postoperative pathological assessment, approximately 14 days after upfront surgery]
Secondary outcome measures (4)
  • LI Positivity Rate According to MMR Status [Time frame: At postoperative pathological assessment, approximately 14 days after upfront surgery]
  • Overall LNM Rate According to MMR Status [Time frame: At postoperative pathological assessment, approximately 14 days after upfront surgery]
  • eCURA Risk Stratification and LI Contribution in the Gastric Cancer ESD Cohort [Time frame: At pathological assessment of the ESD specimen, approximately 14 days after ESD]
  • LNM Rate Among LI-Positive Patients in the cohort undergoing additional gastrectomy after ESD [Time frame: At postoperative pathological assessment, approximately 14 days after additional surgery]

Eligibility criteria

Inclusion criteria

  • Upfront surgery cohort
  • Patients who underwent radical surgery for gastric cancer at Zhongshan Hospital, Fudan University.
  • Patients who did not receive neoadjuvant chemotherapy, radiotherapy, immunotherapy, or other antitumor treatments that may affect the pathological assessment of the primary tumor or lymph node metastasis before surgery.
  • Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after surgery, including Siewert type II and III tumors only.
  • Patients with definite pathological assessment of lymphatic invasion and regional lymph node status.
  • Patients with available and definite MMR status.
  • ESD cohort
  • Patients who underwent ESD for gastric cancer at Zhongshan Hospital, Fudan University.
  • Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after ESD, including Siewert type II and III tumors only.
  • Patients with complete post-ESD pathological information, including histological type, depth of invasion, tumor size, ulcerative findings, lymphatic invasion status, venous invasion status, horizontal margin status, and vertical margin status.
  • Patients with available and definite MMR status.

Exclusion criteria

  • Upfront surgery cohort
  • Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.
  • Patients who received neoadjuvant treatment before surgery, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other systemic antitumor treatments.
  • Patients with missing postoperative pathological information, resulting in inability to determine lymphatic invasion or regional lymph node metastasis status.
  • Patients with missing or indeterminate MMR status.
  • Patients with concurrent malignancies that may interfere with the determination of the origin of lymph node metastasis.
  • ESD cohort
  • Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.
  • Patients with missing post-ESD pathological information that precludes eCURA classification, eCURA risk score calculation, or assessment of lymphatic invasion status.
  • Patients with missing or indeterminate MMR status.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07625735 · B2026-354

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗