About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Clinical Data Collection
Other interventionRetrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Overall Survival
Overall survival is defined as the time from the date of surgery to death from any cause.
Recurrence-Free Survival
Recurrence-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence.
Progression-Free Survival
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.
30-Day Postoperative Complications
Incidence and severity of complications occurring within 30 days following surgery, graded according to the Clavien-Dindo classification.
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