Early Gastric CancerNCT07747688
Retrospective Analysis of Early Gastric Cancer Patients Based on Prospective Clinical Dataset
An observational study of Early Gastric Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Clinical Data Collection
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 8 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Zhi Zheng, Attending surgon, zhengzhi@ccmu.edu.cn
About this study
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
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
- Being tested
- Clinical Data Collection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Data CollectionOther
Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of surgery to up to 10 years post-surgery
Secondary outcomes (43)
Overall Survival
Overall survival is defined as the time from the date of surgery to death from any cause.
Measured: From date of surgery to up to 10 years post-surgery
Recurrence-Free Survival
Recurrence-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence.
Measured: From the date of surgery to 10 years post-surgery
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.
Measured: From the date of surgery to 10 years post-surgery
30-Day Postoperative Complications
Incidence and severity of complications occurring within 30 days following surgery, graded according to the Clavien-Dindo classification.
Measured: From the date of surgery to 30 days post-surgery
30-Day Postoperative Mortality
All-cause mortality occurring within 30 days after surgery, ascertained from medical records and follow-up data.
Measured: From the date of surgery to 30 days post-surgery
Unscheduled Second Surgery Rate
Rate of unscheduled reoperation within 30 days after the initial surgery, identified from surgical records and inpatient documentation.
Measured: From the date of surgery to 30 days post-surgery
Unplanned Return to Hospital Rate
Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery, identified from readmission records.
Measured: From the date of surgery to 30 days post-surgery
Operation Time
Total duration of the surgical procedure, extracted from operative records.
Measured: At the time of surgery
Intraoperative Blood Loss
Estimated total volume of blood loss during the surgical procedure, extracted from operative records and anesthesia documentation.
Measured: At the time of surgery
Postoperative Length of Stay
Total number of days from the date of surgery to hospital discharge, extracted from inpatient medical records.
Measured: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Preoperative Endoscopic Tumor Size
Maximum diameter of the primary tumor (in millimeters) measured by preoperative gastroscopy.
Measured: From 30 days prior to surgery to the date of surgery
Preoperative Endoscopic Macroscopic Type
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.
Measured: From 30 days prior to surgery to the date of surgery
Preoperative CT-Determined Tumor Invasion Depth (cT)
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.
Measured: From 30 days prior to surgery to the date of surgery
Preoperative CT-Determined Lymph Node Status (cN)
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.
Measured: From 30 days prior to surgery to the date of surgery
Preoperative CT Suspicious Lymph Node Count
The number of suspicious metastatic lymph nodes identified during the preoperative enhanced CT examination.
Measured: From 30 days prior to surgery to the date of surgery
Pathological Tumor Invasion Depth (pT)
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.
Measured: From date of surgery to 7 days post-surgery
Pathological Lymph Node Status (pN)
Pathological lymph node metastasis status assessed according to AJCC 8th edition pN category (pN0, pN1, pN2, or pN3) based on postoperative histopathological examination.
Measured: From date of surgery to 7 days post-surgery
Number of Lymph Nodes Examined
Total number of lymph nodes retrieved and examined from the resected specimen.
Measured: From date of surgery to 7 days post-surgery
Number of Positive Lymph Nodes
Total number of lymph nodes with pathologically confirmed metastasis.
Measured: From date of surgery to 7 days post-surgery
Anatomical Location of Metastatic Lymph Nodes
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.
Measured: From date of surgery to 7 days post-surgery
Lymph Node Metastasis Rate
Proportion of positive lymph nodes among total lymph nodes examined (number of positive lymph nodes / total lymph nodes examined × 100%).
Measured: From date of surgery to 7 days post-surgery
Histological Differentiation
Histological differentiation of gastric adenocarcinoma, categorized as well-differentiated, moderately-differentiated, poorly-differentiated, or undifferentiated, based on postoperative pathology.
Measured: From date of surgery to 7 days post-surgery
Lymphovascular Invasion
Presence or absence of lymphatic and/or vascular invasion assessed by postoperative histopathological examination.
Measured: From date of surgery to 7 days post-surgery
Perineural Invasion
Presence or absence of perineural invasion assessed by postoperative histopathological examination.
Measured: From date of surgery to 7 days post-surgery
R0 Resection Rate
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.
Measured: From date of surgery to 7 days post-surgery
Gastric Emptying Scintigraphy
It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
Measured: From 30 days prior to surgery to 10 years post-surgery
Helicobacter pylori Infection Status
Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
Measured: From 30 days prior to surgery to 10 years post-surgery
EORTC QLQ-C30
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.
Measured: From 30 days prior to surgery to 10 years post-surgery
EORTC QLQ-STO22
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.
Measured: From 30 days prior to surgery to 10 years post-surgery
PGSAS-45
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.
Measured: From 30 days prior to surgery to 10 years post-surgery
Serum Albumin
Measured: From 30 days prior to surgery to 10 years post-surgery
Serum Total Protein
Measured: From 30 days prior to surgery to 10 years post-surgery
Hemoglobin
Measured: From 30 days prior to surgery to 10 years post-surgery
Prognostic Nutritional Index (PNI)
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.
Measured: From 30 days prior to surgery to 10 years post-surgery
Inflammatory marker
It will be measured by serum C reactive protein (CRP) level.
Measured: From 30 days prior to surgery to 10 years post-surgery
Carcinoembryonic Antigen (CEA)
Measured: From 30 days prior to surgery to 10 years post-surgery
Carbohydrate Antigen 19-9 (CA19-9)
Measured: From 30 days prior to surgery to 10 years post-surgery
Carbohydrate Antigen 72-4 (CA72-4)
Measured: From 30 days prior to surgery to 10 years post-surgery
Alpha-Fetoprotein (AFP)
Measured: From 30 days prior to surgery to 10 years post-surgery
Carbohydrate Antigen 125 (CA125)
Measured: From 30 days prior to surgery to 10 years post-surgery
Time to First Flatus
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.
Measured: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Resumption of Oral Intake
Time from the date of surgery to the resumption of oral intake (liquid or solid diet), extracted from postoperative dietary records.
Measured: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Overall Hospitalization Cost
Measured: From the time of admission to the time of discharge, assessed up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start8 May 2026
- Primary completion8 May 2027 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JunZhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747688
- Sponsor's protocol ID
- 2026-P2-266-01
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No