MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer
16 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
3000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Zhaoqing Tang
- Telefoonnummer: 86-021-64041990
- E-mail: tang.zhaoqing@zs-hospital.sh.cn
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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).
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
LI Positivity Rate According to MMR Status
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
30 november 2026
Studie voltooiing (Geschat)
31 juli 2027
Studieregistratiedata
Eerst ingediend
19 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 mei 2026
Eerst geplaatst (Werkelijk)
4 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
16 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- B2026-354
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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