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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Clinical Data Collection (Other)
结局指标
主要结局
Disease-Free Survival
时间窗: 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.
次要结局
- Overall Survival(From date of surgery to up to 10 years post-surgery)
- Recurrence-Free Survival(From the date of surgery to 10 years post-surgery)
- Progression-Free Survival(From the date of surgery to 10 years post-surgery)
- 30-Day Postoperative Complications(From the date of surgery to 30 days post-surgery)
- 30-Day Postoperative Mortality(From the date of surgery to 30 days post-surgery)
- Unscheduled Second Surgery Rate(From the date of surgery to 30 days post-surgery)
- Unplanned Return to Hospital Rate(From the date of surgery to 30 days post-surgery)
- Operation Time(At the time of surgery)
- Intraoperative Blood Loss(At the time of surgery)
- Postoperative Length of Stay(From date of surgery until date of hospital discharge, assessed up to 2 weeks)
- Preoperative Endoscopic Tumor Size(From 30 days prior to surgery to the date of surgery)
- Preoperative Endoscopic Macroscopic Type(From 30 days prior to surgery to the date of surgery)
- Preoperative CT-Determined Tumor Invasion Depth (cT)(From 30 days prior to surgery to the date of surgery)
- Preoperative CT-Determined Lymph Node Status (cN)(From 30 days prior to surgery to the date of surgery)
- Preoperative CT Suspicious Lymph Node Count(From 30 days prior to surgery to the date of surgery)
- Pathological Tumor Invasion Depth (pT)(From date of surgery to 7 days post-surgery)
- Pathological Lymph Node Status (pN)(From date of surgery to 7 days post-surgery)
- Number of Lymph Nodes Examined(From date of surgery to 7 days post-surgery)
- Number of Positive Lymph Nodes(From date of surgery to 7 days post-surgery)
- Anatomical Location of Metastatic Lymph Nodes(From date of surgery to 7 days post-surgery)
- Lymph Node Metastasis Rate(From date of surgery to 7 days post-surgery)
- Histological Differentiation(From date of surgery to 7 days post-surgery)
- Lymphovascular Invasion(From date of surgery to 7 days post-surgery)
- Perineural Invasion(From date of surgery to 7 days post-surgery)
- R0 Resection Rate(From date of surgery to 7 days post-surgery)
- Gastric Emptying Scintigraphy(From 30 days prior to surgery to 10 years post-surgery)
- Helicobacter pylori Infection Status(From 30 days prior to surgery to 10 years post-surgery)
- EORTC QLQ-C30(From 30 days prior to surgery to 10 years post-surgery)
- EORTC QLQ-STO22(From 30 days prior to surgery to 10 years post-surgery)
- PGSAS-45(From 30 days prior to surgery to 10 years post-surgery)
- Serum Albumin(From 30 days prior to surgery to 10 years post-surgery)
- Serum Total Protein(From 30 days prior to surgery to 10 years post-surgery)
- Hemoglobin(From 30 days prior to surgery to 10 years post-surgery)
- Prognostic Nutritional Index (PNI)(From 30 days prior to surgery to 10 years post-surgery)
- Inflammatory marker(From 30 days prior to surgery to 10 years post-surgery)
- Carcinoembryonic Antigen (CEA)(From 30 days prior to surgery to 10 years post-surgery)
- Carbohydrate Antigen 19-9 (CA19-9)(From 30 days prior to surgery to 10 years post-surgery)
- Carbohydrate Antigen 72-4 (CA72-4)(From 30 days prior to surgery to 10 years post-surgery)
- Alpha-Fetoprotein (AFP)(From 30 days prior to surgery to 10 years post-surgery)
- Carbohydrate Antigen 125 (CA125)(From 30 days prior to surgery to 10 years post-surgery)
- Time to First Flatus(From date of surgery until date of hospital discharge, assessed up to 2 weeks)
- Resumption of Oral Intake(From date of surgery until date of hospital discharge, assessed up to 2 weeks)
- Overall Hospitalization Cost(From the time of admission to the time of discharge, assessed up to 3 weeks)
研究者
JunZhang
Chief Surgeon
Beijing Friendship Hospital