Retrospective Analysis of Early Gastric Cancer Patients Based on Prospective Clinical Dataset
31 de julio de 2026 actualizado por: JunZhang, Beijing Friendship Hospital
Establishing an Innovative Cohort for Chinese Early Gastric Cancer Patients Based on the National Clinical Research Center for Digestive Diseases Prospective Database: A Retrospective Study
The goal of this retrospective observational cohort study is to describe the real-world clinicopathological characteristics, evolving treatment patterns, and long-term oncological outcomes of early gastric cancer (EGC) patients in China, utilizing a large prospective clinical database.
The main questions it aims to answer are:
How do different treatment modalities, including endoscopic resection, laparoscopic surgery, open surgery, and combined laparoscopic-endoscopic approaches, influence the long-term survival (Overall Survival and Disease-Free Survival) and recurrence patterns in Chinese EGC patients? What are the key clinicopathological factors affecting prognosis in this population? This study will retrospectively enroll approximately 5000 patients with histopathologically confirmed gastric adenocarcinoma staged as early gastric cancer (per AJCC 8th edition) from the information database of the National Clinical Research Center for Digestive Diseases. Researchers will systematically collect baseline demographics, treatment details, surgical complications, pathological staging, and longitudinal follow-up data (up to 10 years post-surgery) for all eligible patients. By comparing the short-term safety profiles and long-term survival benefits across different treatment groups and identifying risk factors for recurrence, this study aims to provide high-quality, China-specific evidence to guide standardized and individualized clinical decision-making for early gastric cancer.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
5000
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: Zhi zheng, Attending surgon
- Número de teléfono: +86-13811132175
- Correo electrónico: zhengzhi@ccmu.edu.cn
Ubicaciones de estudio
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Beijing, Porcelana
- Reclutamiento
- Beijing Friendship hospital, Capital Medical University
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Contacto:
- Zhi Zheng, Attending surgon
- Correo electrónico: zhengzhi@ccmu.edu.cn
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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
The study population will be derived from the information database of the National Clinical Research Center for Digestive Diseases at Beijing Friendship Hospital, Capital Medical University.
This retrospective cohort will include approximately 5000 patients who were diagnosed with early gastric cancer.
All patients included in the database during this period who meet the eligibility criteria will be consecutively enrolled.
The source population consists of patients who visited Beijing Friendship Hospital for the diagnosis and treatment of gastric cancer.
The database contains comprehensive clinicopathological data, treatment details, and longitudinal follow-up information for all enrolled patients.
Beijing Friendship Hospital is a large tertiary referral center in China serving a broad geographic catchment area, and the study population is expected to reflect a diverse range of patient demographics and clinical presentations.
Descripción
Inclusion Criteria:
- patients aged between 18 and 90 years;
- preoperative endoscopic biopsy-confirmed gastric adenocarcinoma;
- clinical stage early gastric (cT1NxM0) cancer according to the AJCC 8th edition TNM staging system;
- patients who have signed a broad informed consent.
- Received primary treatment (including endoscopic resection, laparoscopic surgery, open surgery, or combined laparoscopic-endoscopic approach) at Beijing Friendship Hospital.
Exclusion Criteria:
- pregnant or breastfeeding women;
- Preoperative or intraoperative diagnosis remained indeterminate due to insufficient pathological or imaging evidence, such that the patient could not be clearly classified as early gastric cancer prior to treatment;
- Critical clinical data were severely incomplete or missing；
- Completely lost to follow-up with no available information to confirm survival 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 |
|---|---|
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Early Gastric Cancer Cohort
A retrospective cohort of approximately 5000 patients with histopathologically confirmed early gastric cancer (AJCC 8th edition) treated at Beijing Friendship Hospital.
Data were extracted from the National Clinical Research Center for Digestive Diseases information database.
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Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease-Free Survival
Periodo de tiempo: From date of surgery to up to 10 years post-surgery
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Disease-free survival is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause.
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From date of surgery to up to 10 years post-surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival
Periodo de tiempo: From date of surgery to up to 10 years post-surgery
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Overall survival is defined as the time from the date of surgery to death from any cause.
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From date of surgery to up to 10 years post-surgery
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Recurrence-Free Survival
Periodo de tiempo: From the date of surgery to 10 years post-surgery
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Recurrence-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence.
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From the date of surgery to 10 years post-surgery
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Progression-Free Survival
Periodo de tiempo: From the date of surgery to 10 years post-surgery
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Progression-free survival is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause.
Disease progression includes recurrence, metastasis, or progression of residual disease.
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From the date of surgery to 10 years post-surgery
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30-Day Postoperative Complications
Periodo de tiempo: From the date of surgery to 30 days post-surgery
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Incidence and severity of complications occurring within 30 days following surgery, graded according to the Clavien-Dindo classification.
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From the date of surgery to 30 days post-surgery
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30-Day Postoperative Mortality
Periodo de tiempo: From the date of surgery to 30 days post-surgery
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All-cause mortality occurring within 30 days after surgery, ascertained from medical records and follow-up data.
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From the date of surgery to 30 days post-surgery
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Unscheduled Second Surgery Rate
Periodo de tiempo: From the date of surgery to 30 days post-surgery
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Rate of unscheduled reoperation within 30 days after the initial surgery, identified from surgical records and inpatient documentation.
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From the date of surgery to 30 days post-surgery
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Unplanned Return to Hospital Rate
Periodo de tiempo: From the date of surgery to 30 days post-surgery
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Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery, identified from readmission records.
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From the date of surgery to 30 days post-surgery
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Operation Time
Periodo de tiempo: At the time of surgery
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Total duration of the surgical procedure, extracted from operative records.
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At the time of surgery
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Intraoperative Blood Loss
Periodo de tiempo: At the time of surgery
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Estimated total volume of blood loss during the surgical procedure, extracted from operative records and anesthesia documentation.
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At the time of surgery
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Postoperative Length of Stay
Periodo de tiempo: From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Total number of days from the date of surgery to hospital discharge, extracted from inpatient medical records.
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From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Preoperative Endoscopic Tumor Size
Periodo de tiempo: From 30 days prior to surgery to the date of surgery
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Maximum diameter of the primary tumor (in millimeters) measured by preoperative gastroscopy.
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From 30 days prior to surgery to the date of surgery
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Preoperative Endoscopic Macroscopic Type
Periodo de tiempo: From 30 days prior to surgery to the date of surgery
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Macroscopic type of the primary tumor assessed by preoperative gastroscopy, classified as elevated (0-I), flat (0-IIa, IIb, IIc), or depressed (0-III) types according to the Paris classification.
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From 30 days prior to surgery to the date of surgery
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Preoperative CT-Determined Tumor Invasion Depth (cT)
Periodo de tiempo: From 30 days prior to surgery to the date of surgery
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Depth of tumor invasion assessed by preoperative contrast-enhanced CT, categorized as cT1, cT2, cT3, or cT4 according to the AJCC 8th edition TNM staging system.
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From 30 days prior to surgery to the date of surgery
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Preoperative CT-Determined Lymph Node Status (cN)
Periodo de tiempo: From 30 days prior to surgery to the date of surgery
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Lymph node metastasis status assessed by preoperative contrast-enhanced CT, categorized as cN0, cN1, cN2, or cN3 according to the AJCC 8th edition TNM staging system.
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From 30 days prior to surgery to the date of surgery
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Preoperative CT Suspicious Lymph Node Count
Periodo de tiempo: From 30 days prior to surgery to the date of surgery
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The number of suspicious metastatic lymph nodes identified during the preoperative enhanced CT examination.
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From 30 days prior to surgery to the date of surgery
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Pathological Tumor Invasion Depth (pT)
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Pathological depth of tumor invasion assessed according to AJCC 8th edition pT category (pT1a, pT1b, pT2, pT3, or pT4) based on postoperative histopathological examination of the resected specimen.
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From date of surgery to 7 days post-surgery
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Pathological Lymph Node Status (pN)
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Pathological lymph node metastasis status assessed according to AJCC 8th edition pN category (pN0, pN1, pN2, or pN3) based on postoperative histopathological examination.
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From date of surgery to 7 days post-surgery
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Number of Lymph Nodes Examined
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Total number of lymph nodes retrieved and examined from the resected specimen.
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From date of surgery to 7 days post-surgery
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Number of Positive Lymph Nodes
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Total number of lymph nodes with pathologically confirmed metastasis.
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From date of surgery to 7 days post-surgery
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Anatomical Location of Metastatic Lymph Nodes
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Anatomical distribution of pathologically confirmed metastatic lymph nodes identified in the resected specimen, categorized by lymph node station (e.g., No.1, No.3, No.4sb, No.7, etc.) according to the Japanese Gastric Cancer Association (JGCA) classification system.
Data will be extracted from postoperative pathology reports.
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From date of surgery to 7 days post-surgery
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Lymph Node Metastasis Rate
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Proportion of positive lymph nodes among total lymph nodes examined (number of positive lymph nodes / total lymph nodes examined × 100%).
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From date of surgery to 7 days post-surgery
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Histological Differentiation
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Histological differentiation of gastric adenocarcinoma, categorized as well-differentiated, moderately-differentiated, poorly-differentiated, or undifferentiated, based on postoperative pathology.
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From date of surgery to 7 days post-surgery
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Lymphovascular Invasion
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Presence or absence of lymphatic and/or vascular invasion assessed by postoperative histopathological examination.
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From date of surgery to 7 days post-surgery
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Perineural Invasion
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Presence or absence of perineural invasion assessed by postoperative histopathological examination.
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From date of surgery to 7 days post-surgery
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R0 Resection Rate
Periodo de tiempo: From date of surgery to 7 days post-surgery
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Proportion of patients with no residual tumor microscopically confirmed on both the primary tumor resection margins and resected lymph nodes, assessed by postoperative pathological examination.
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From date of surgery to 7 days post-surgery
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Gastric Emptying Scintigraphy
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
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From 30 days prior to surgery to 10 years post-surgery
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Helicobacter pylori Infection Status
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
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From 30 days prior to surgery to 10 years post-surgery
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EORTC QLQ-C30
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC-QLQ-C30) includes 30 items measuring functional, symptomatic, and global quality-of-life domains.
Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
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From 30 days prior to surgery to 10 years post-surgery
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EORTC QLQ-STO22
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module 22(EORTC-QLQ-STO22) supplement contains 22 items assessing symptoms and concerns specific to gastric cancer.
Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden.
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From 30 days prior to surgery to 10 years post-surgery
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PGSAS-45
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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The Postgastrectomy Syndrome Assessment Scale 45(PGSAS-45), consisting of 45 items, will be used to comprehensively evaluate postgastrectomy symptoms, digestive status, and daily life functions.
All subscale scores are linearly transformed to a 0-100 range.
For symptom-related subscales, higher scores indicate greater symptom burden; for functional and quality of life subscales, higher scores indicate better functioning or quality of life.
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From 30 days prior to surgery to 10 years post-surgery
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Serum Albumin
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Serum Total Protein
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Hemoglobin
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Prognostic Nutritional Index (PNI)
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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It is a combined score based on serum albumin level and total lymphocyte count.
It is calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (cells/μL).
Higher scores indicate better nutritional and immunological status.
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From 30 days prior to surgery to 10 years post-surgery
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Inflammatory marker
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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It will be measured by serum C reactive protein (CRP) level.
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From 30 days prior to surgery to 10 years post-surgery
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Carcinoembryonic Antigen (CEA)
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Carbohydrate Antigen 19-9 (CA19-9)
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Carbohydrate Antigen 72-4 (CA72-4)
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Alpha-Fetoprotein (AFP)
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Carbohydrate Antigen 125 (CA125)
Periodo de tiempo: From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Time to First Flatus
Periodo de tiempo: From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Time from the date of surgery to the first passage of flatus, indicating recovery of gastrointestinal motility.
Data will be extracted from postoperative recovery records.
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From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Resumption of Oral Intake
Periodo de tiempo: From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Time from the date of surgery to the resumption of oral intake (liquid or solid diet), extracted from postoperative dietary records.
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From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Overall Hospitalization Cost
Periodo de tiempo: From the time of admission to the time of discharge, assessed up to 3 weeks
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From the time of admission to the time of discharge, assessed up to 3 weeks
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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 (Actual)
8 de mayo de 2026
Finalización primaria (Estimado)
8 de mayo de 2027
Finalización del estudio (Estimado)
8 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2026
Publicado por primera vez (Actual)
5 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-P2-266-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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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