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

NCT07747688 | Recruiting

• 1 other identifier: 2026-P2-266-01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival

  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 Outcomes (43)

• Overall Survival

  From date of surgery to up to 10 years post-surgery

• Recurrence-Free Survival

  From the date of surgery to 10 years post-surgery

• Progression-Free Survival

  From the date of surgery to 10 years post-surgery

• 30-Day Postoperative Complications

  From the date of surgery to 30 days post-surgery

• 30-Day Postoperative Mortality

  From the date of surgery to 30 days post-surgery

Study Arms (1)

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

Interventions

Clinical Data Collection OTHER

Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.

Early Gastric Cancer Cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhi Zheng, Attending surgon

CONTACT

+86-13811132175; zhengzhi@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Surgeon

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): May 8, 2027
• Study Completion (Estimated): June 8, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)