MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer
16 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
3000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zhaoqing Tang
- Número de teléfono: 86-021-64041990
- Correo electrónico: tang.zhaoqing@zs-hospital.sh.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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).
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
LI Positivity Rate According to MMR Status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
30 de noviembre de 2026
Finalización del estudio (Estimado)
31 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B2026-354
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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