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.
調査の概要
状態
まだ募集していません
研究の種類
観察的
入学 (推定)
3000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Zhaoqing Tang
- 電話番号：86-021-64041990
- メール：tang.zhaoqing@zs-hospital.sh.cn
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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).
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
dMMR gastric cancer
Patients with gastric cancer classified as deficient mismatch repair (dMMR) based on routine pathological testing.
|
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.
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.
|
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.
Lymphatic invasion status was determined from routine pathological reports and classified as LI-positive or LI-negative.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
LI Positivity Rate According to MMR Status
時間枠：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
時間枠：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
時間枠：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.
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At pathological assessment of the ESD specimen, approximately 14 days after ESD
|
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LNM Rate Among LI-Positive Patients in the cohort undergoing additional gastrectomy after ESD
時間枠：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
|
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ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2026年11月30日
研究の完了 (推定)
2027年7月31日
試験登録日
最初に提出
2026年5月19日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- B2026-354
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
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