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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorBeijing Friendship Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Clinical Data Collection

    Other intervention

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

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Early Gastric Cancer Cohort1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Overall Survival

Overall survival is defined as the time from the date of surgery to death from any cause.

Time frame
From date of surgery to up to 10 years post-surgery
2

Recurrence-Free Survival

Recurrence-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence.

Time frame
From the date of surgery to 10 years post-surgery
3

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.

Time frame
From the date of surgery to 10 years post-surgery
4

30-Day Postoperative Complications

Incidence and severity of complications occurring within 30 days following surgery, graded according to the Clavien-Dindo classification.

Time frame
From the date of surgery to 30 days post-surgery

Other outcomes

Sponsors and contacts

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