Retrospective Analysis of Early Gastric Cancer Patients Based on Prospective Clinical Dataset
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical Data Collection.
- Who it may be relevant to
- Registry conditions: Early Gastric Cancer. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Disease-Free Survival [Time frame: From date of surgery to up to 10 years post-surgery]
Secondary outcome measures (12)
- Overall Survival [Time frame: 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]
- Progression-Free Survival [Time frame: 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]
- 30-Day Postoperative Mortality [Time frame: 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]
- Unplanned Return to Hospital Rate [Time frame: From the date of surgery to 30 days post-surgery]
- Operation Time [Time frame: At the time of surgery]
- Intraoperative Blood Loss [Time frame: 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]
- Preoperative Endoscopic Tumor Size [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Friendship Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07747688 · 2026-P2-266-01