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Retrospective Analysis of Early Gastric Cancer Patients Based on Prospective Clinical Dataset

31 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

5000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Zhi zheng, Attending surgon
  • Numéro de téléphone: +86-13811132175
  • E-mail: zhengzhi@ccmu.edu.cn

Lieux d'étude

  • Chine
      • Beijing, Chine
        • Recrutement
        • Beijing Friendship hospital, Capital Medical University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: Clinical Data Collection
Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Disease-Free Survival
Délai: From date of surgery to up to 10 years post-surgery
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.
From date of surgery to up to 10 years post-surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival
Délai: From date of surgery to up to 10 years post-surgery
Overall survival is defined as the time from the date of surgery to death from any cause.
From date of surgery to up to 10 years post-surgery
Recurrence-Free Survival
Délai: From the date of surgery to 10 years post-surgery
Recurrence-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence.
From the date of surgery to 10 years post-surgery
Progression-Free Survival
Délai: From the date of surgery to 10 years post-surgery
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.
From the date of surgery to 10 years post-surgery
30-Day Postoperative Complications
Délai: From the date of surgery to 30 days post-surgery
Incidence and severity of complications occurring within 30 days following surgery, graded according to the Clavien-Dindo classification.
From the date of surgery to 30 days post-surgery
30-Day Postoperative Mortality
Délai: From the date of surgery to 30 days post-surgery
All-cause mortality occurring within 30 days after surgery, ascertained from medical records and follow-up data.
From the date of surgery to 30 days post-surgery
Unscheduled Second Surgery Rate
Délai: From the date of surgery to 30 days post-surgery
Rate of unscheduled reoperation within 30 days after the initial surgery, identified from surgical records and inpatient documentation.
From the date of surgery to 30 days post-surgery
Unplanned Return to Hospital Rate
Délai: From the date of surgery to 30 days post-surgery
Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery, identified from readmission records.
From the date of surgery to 30 days post-surgery
Operation Time
Délai: At the time of surgery
Total duration of the surgical procedure, extracted from operative records.
At the time of surgery
Intraoperative Blood Loss
Délai: At the time of surgery
Estimated total volume of blood loss during the surgical procedure, extracted from operative records and anesthesia documentation.
At the time of surgery
Postoperative Length of Stay
Délai: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Total number of days from the date of surgery to hospital discharge, extracted from inpatient medical records.
From date of surgery until date of hospital discharge, assessed up to 2 weeks
Preoperative Endoscopic Tumor Size
Délai: From 30 days prior to surgery to the date of surgery
Maximum diameter of the primary tumor (in millimeters) measured by preoperative gastroscopy.
From 30 days prior to surgery to the date of surgery
Preoperative Endoscopic Macroscopic Type
Délai: From 30 days prior to surgery to the date of surgery
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.
From 30 days prior to surgery to the date of surgery
Preoperative CT-Determined Tumor Invasion Depth (cT)
Délai: From 30 days prior to surgery to the date of surgery
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.
From 30 days prior to surgery to the date of surgery
Preoperative CT-Determined Lymph Node Status (cN)
Délai: From 30 days prior to surgery to the date of surgery
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.
From 30 days prior to surgery to the date of surgery
Preoperative CT Suspicious Lymph Node Count
Délai: From 30 days prior to surgery to the date of surgery
The number of suspicious metastatic lymph nodes identified during the preoperative enhanced CT examination.
From 30 days prior to surgery to the date of surgery
Pathological Tumor Invasion Depth (pT)
Délai: From date of surgery to 7 days post-surgery
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.
From date of surgery to 7 days post-surgery
Pathological Lymph Node Status (pN)
Délai: From date of surgery to 7 days post-surgery
Pathological lymph node metastasis status assessed according to AJCC 8th edition pN category (pN0, pN1, pN2, or pN3) based on postoperative histopathological examination.
From date of surgery to 7 days post-surgery
Number of Lymph Nodes Examined
Délai: From date of surgery to 7 days post-surgery
Total number of lymph nodes retrieved and examined from the resected specimen.
From date of surgery to 7 days post-surgery
Number of Positive Lymph Nodes
Délai: From date of surgery to 7 days post-surgery
Total number of lymph nodes with pathologically confirmed metastasis.
From date of surgery to 7 days post-surgery
Anatomical Location of Metastatic Lymph Nodes
Délai: From date of surgery to 7 days post-surgery
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.
From date of surgery to 7 days post-surgery
Lymph Node Metastasis Rate
Délai: From date of surgery to 7 days post-surgery
Proportion of positive lymph nodes among total lymph nodes examined (number of positive lymph nodes / total lymph nodes examined × 100%).
From date of surgery to 7 days post-surgery
Histological Differentiation
Délai: From date of surgery to 7 days post-surgery
Histological differentiation of gastric adenocarcinoma, categorized as well-differentiated, moderately-differentiated, poorly-differentiated, or undifferentiated, based on postoperative pathology.
From date of surgery to 7 days post-surgery
Lymphovascular Invasion
Délai: From date of surgery to 7 days post-surgery
Presence or absence of lymphatic and/or vascular invasion assessed by postoperative histopathological examination.
From date of surgery to 7 days post-surgery
Perineural Invasion
Délai: From date of surgery to 7 days post-surgery
Presence or absence of perineural invasion assessed by postoperative histopathological examination.
From date of surgery to 7 days post-surgery
R0 Resection Rate
Délai: From date of surgery to 7 days post-surgery
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.
From date of surgery to 7 days post-surgery
Gastric Emptying Scintigraphy
Délai: From 30 days prior to surgery to 10 years post-surgery
It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
From 30 days prior to surgery to 10 years post-surgery
Helicobacter pylori Infection Status
Délai: From 30 days prior to surgery to 10 years post-surgery
Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
From 30 days prior to surgery to 10 years post-surgery
EORTC QLQ-C30
Délai: From 30 days prior to surgery to 10 years post-surgery
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.
From 30 days prior to surgery to 10 years post-surgery
EORTC QLQ-STO22
Délai: From 30 days prior to surgery to 10 years post-surgery
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.
From 30 days prior to surgery to 10 years post-surgery
PGSAS-45
Délai: From 30 days prior to surgery to 10 years post-surgery
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.
From 30 days prior to surgery to 10 years post-surgery
Serum Albumin
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Serum Total Protein
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Hemoglobin
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Prognostic Nutritional Index (PNI)
Délai: From 30 days prior to surgery to 10 years post-surgery
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.
From 30 days prior to surgery to 10 years post-surgery
Inflammatory marker
Délai: From 30 days prior to surgery to 10 years post-surgery
It will be measured by serum C reactive protein (CRP) level.
From 30 days prior to surgery to 10 years post-surgery
Carcinoembryonic Antigen (CEA)
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Carbohydrate Antigen 19-9 (CA19-9)
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Carbohydrate Antigen 72-4 (CA72-4)
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Alpha-Fetoprotein (AFP)
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Carbohydrate Antigen 125 (CA125)
Délai: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Time to First Flatus
Délai: From date of surgery until date of hospital discharge, assessed up to 2 weeks
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.
From date of surgery until date of hospital discharge, assessed up to 2 weeks
Resumption of Oral Intake
Délai: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Time from the date of surgery to the resumption of oral intake (liquid or solid diet), extracted from postoperative dietary records.
From date of surgery until date of hospital discharge, assessed up to 2 weeks
Overall Hospitalization Cost
Délai: From the time of admission to the time of discharge, assessed up to 3 weeks
From the time of admission to the time of discharge, assessed up to 3 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beijing Friendship Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 mai 2026

Achèvement primaire (Estimé)

8 mai 2027

Achèvement de l'étude (Estimé)

8 juin 2027

Dates d'inscription aux études

Première soumission

31 juillet 2026

Première soumission répondant aux critères de contrôle qualité

31 juillet 2026

Première publication (Réel)

5 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-P2-266-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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