Retrospective Analysis of Early Gastric Cancer Patients Based on Prospective Clinical Dataset
31 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
5000
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Zhi zheng, Attending surgon
- Número de telefone: +86-13811132175
- E-mail: zhengzhi@ccmu.edu.cn
Locais de estudo
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Beijing, China
- Recrutamento
- Beijing Friendship hospital, Capital Medical University
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Contato:
- Zhi Zheng, Attending surgon
- E-mail: zhengzhi@ccmu.edu.cn
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Disease-Free Survival
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Survival
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de maio de 2026
Conclusão Primária (Estimado)
8 de maio de 2027
Conclusão do estudo (Estimado)
8 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
31 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de julho de 2026
Primeira postagem (Real)
5 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-P2-266-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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