Beijing Friendship Hospital, Capital Medical University
Beijing, China
Location status: Recruiting
NCT Number: NCT07747688
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Beijing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.
Time frame: From date of surgery to up to 10 years post-surgery
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
Overall survival is defined as the time from the date of surgery to death from any cause.
Time frame: From the date of surgery to 10 years post-surgery
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
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 30 days post-surgery
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
All-cause mortality occurring within 30 days after surgery, ascertained from medical records and follow-up data.
Time frame: From the date of surgery to 30 days post-surgery
Rate of unscheduled reoperation within 30 days after the initial surgery, identified from surgical records and inpatient documentation.
Time frame: From the date of surgery to 30 days post-surgery
Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery, identified from readmission records.
Time frame: At the time of surgery
Total duration of the surgical procedure, extracted from operative records.
Time frame: At the time of surgery
Estimated total volume of blood loss during the surgical procedure, extracted from operative records and anesthesia documentation.
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Total number of days from the date of surgery to hospital discharge, extracted from inpatient medical records.
Time frame: From 30 days prior to surgery to the date of surgery
Maximum diameter of the primary tumor (in millimeters) measured by preoperative gastroscopy.
Time frame: From 30 days prior to surgery to the date of surgery
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.
Time frame: From 30 days prior to surgery to the date of surgery
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.
Time frame: From 30 days prior to surgery to the date of surgery
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.
Time frame: From 30 days prior to surgery to the date of surgery
The number of suspicious metastatic lymph nodes identified during the preoperative enhanced CT examination.
Time frame: From date of surgery to 7 days post-surgery
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.
Time frame: From date of surgery to 7 days post-surgery
Pathological lymph node metastasis status assessed according to AJCC 8th edition pN category (pN0, pN1, pN2, or pN3) based on postoperative histopathological examination.
Time frame: From date of surgery to 7 days post-surgery
Total number of lymph nodes retrieved and examined from the resected specimen.
Time frame: From date of surgery to 7 days post-surgery
Total number of lymph nodes with pathologically confirmed metastasis.
Time frame: From date of surgery to 7 days post-surgery
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.
Time frame: From date of surgery to 7 days post-surgery
Proportion of positive lymph nodes among total lymph nodes examined (number of positive lymph nodes / total lymph nodes examined × 100%).
Time frame: From date of surgery to 7 days post-surgery
Histological differentiation of gastric adenocarcinoma, categorized as well-differentiated, moderately-differentiated, poorly-differentiated, or undifferentiated, based on postoperative pathology.
Time frame: From date of surgery to 7 days post-surgery
Presence or absence of lymphatic and/or vascular invasion assessed by postoperative histopathological examination.
Time frame: From date of surgery to 7 days post-surgery
Presence or absence of perineural invasion assessed by postoperative histopathological examination.
Time frame: From date of surgery to 7 days post-surgery
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.
Time frame: From 30 days prior to surgery to 10 years post-surgery
It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
Time frame: From 30 days prior to surgery to 10 years post-surgery
Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
Time frame: From 30 days prior to surgery to 10 years post-surgery
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.
Time frame: From 30 days prior to surgery to 10 years post-surgery
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.
Time frame: From 30 days prior to surgery to 10 years post-surgery
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.
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From 30 days prior to surgery to 10 years post-surgery
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.
Time frame: From 30 days prior to surgery to 10 years post-surgery
It will be measured by serum C reactive protein (CRP) level.
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From 30 days prior to surgery to 10 years post-surgery
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
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.
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Time from the date of surgery to the resumption of oral intake (liquid or solid diet), extracted from postoperative dietary records.
Time frame: From the time of admission to the time of discharge, assessed up to 3 weeks
Contact information is provided by the study sponsor or research team.
Beijing Friendship Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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