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

2026年6月16日 更新者：Shanghai Zhongshan Hospital

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

3000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma treated at Zhongshan Hospital, Fudan University. The study population includes two retrospective cohorts: patients who underwent upfront radical surgery between January 2018 and April 2026, and patients who underwent endoscopic submucosal dissection (ESD) between January 2021 and March 2026 with available mismatch repair (MMR) status. Patients are classified according to MMR status as deficient mismatch repair (dMMR) or proficient mismatch repair (pMMR).

描述

Inclusion Criteria:

  1. 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.

  2. 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:

  1. 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.

  2. 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
dMMR gastric cancer
Patients with gastric cancer classified as deficient mismatch repair (dMMR) based on routine pathological testing.
其他：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.
其他：Lymphatic invasion status
Lymphatic invasion status was determined from routine pathological reports and classified as LI-positive or LI-negative.
pMMR gastric cancer
Patients with gastric cancer classified as proficient mismatch repair (pMMR) based on routine pathological assessment.
其他：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.
其他：Lymphatic invasion status
Lymphatic invasion status was determined from routine pathological reports and classified as LI-positive or LI-negative.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients
大体时间：At postoperative pathological assessment, approximately 14 days after upfront surgery
LI positivity is defined as lymphatic invasion explicitly documented in the pathological report or tumor emboli within lymphatic vessels confirmed by D2-40 immunohistochemistry. LNM is defined as regional lymph node metastasis confirmed by postoperative pathological examination. The LNM rate among LI-positive patients is calculated as the number of patients with LNM divided by the total number of LI-positive patients in the corresponding group.
At postoperative pathological assessment, approximately 14 days after upfront surgery

次要结果测量

结果测量
措施说明
大体时间
LI Positivity Rate According to MMR Status
大体时间：At postoperative pathological assessment, approximately 14 days after upfront surgery
This outcome evaluates differences in LI positivity rate between patients with dMMR and pMMR gastric cancer. LI positivity rate is calculated as the number of LI-positive patients divided by the total number of patients in each MMR group.
At postoperative pathological assessment, approximately 14 days after upfront surgery
Overall LNM Rate According to MMR Status
大体时间：At postoperative pathological assessment, approximately 14 days after upfront surgery
This outcome evaluates differences in overall LNM rate between patients with dMMR and pMMR gastric cancer. Overall LNM rate is calculated as the number of patients with pathologically confirmed LNM divided by the total number of patients in each MMR group.
At postoperative pathological assessment, approximately 14 days after upfront surgery
eCURA Risk Stratification and LI Contribution in the Gastric Cancer ESD Cohort
大体时间：At pathological assessment of the ESD specimen, approximately 14 days after ESD
This outcome evaluates differences in eCURA classification, eCURA risk score distribution, and the contribution of LI to the risk score between dMMR and pMMR patients in the gastric cancer ESD cohort. LI contribution is assessed based on its role in eCURA-C2 classification and/or its component score contribution within the eCURA risk scoring system.
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
大体时间：At postoperative pathological assessment, approximately 14 days after additional surgery
This outcome evaluates differences in LNM risk between LI-positive dMMR and pMMR patients with early gastric cancer who underwent additional surgery after ESD. LNM is defined as regional lymph node metastasis confirmed by pathological examination of the additional surgical specimen. LNM rate is calculated as the number of patients with LNM divided by the total number of LI-positive patients in each MMR group.
At postoperative pathological assessment, approximately 14 days after additional surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Zhongshan Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年11月30日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • B2026-354

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be publicly shared due to patient privacy concerns and institutional data protection regulations. De-identified aggregate data may be made available from the corresponding author upon reasonable request and with appropriate institutional approval.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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