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

July 31, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Clinical Data Collection
Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-Free Survival
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At the time of surgery
Total duration of the surgical procedure, extracted from operative records.
At the time of surgery
Intraoperative Blood Loss
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From 30 days prior to surgery to 10 years post-surgery
From 30 days prior to surgery to 10 years post-surgery
Hemoglobin
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-P2-266-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings