Retrospective Analysis of Early Gastric Cancer Patients Based on Prospective Clinical Dataset
2026年7月31日 更新者：JunZhang、Beijing Friendship Hospital
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.
調査の概要
研究の種類
観察的
入学 (推定)
5000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Zhi zheng, Attending surgon
- 電話番号：+86-13811132175
- メール：zhengzhi@ccmu.edu.cn
研究場所
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Beijing、中国
- 募集
- Beijing Friendship hospital, Capital Medical University
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コンタクト：
- Zhi Zheng, Attending surgon
- メール：zhengzhi@ccmu.edu.cn
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disease-Free Survival
時間枠：From date of surgery to up to 10 years post-surgery
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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.
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From date of surgery to up to 10 years post-surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival
時間枠：From date of surgery to up to 10 years post-surgery
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Overall survival is defined as the time from the date of surgery to death from any cause.
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From date of surgery to up to 10 years post-surgery
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Recurrence-Free Survival
時間枠：From the date of surgery to 10 years post-surgery
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Recurrence-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence.
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From the date of surgery to 10 years post-surgery
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Progression-Free Survival
時間枠：From the date of surgery to 10 years post-surgery
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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.
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From the date of surgery to 10 years post-surgery
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30-Day Postoperative Complications
時間枠：From the date of surgery to 30 days post-surgery
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Incidence and severity of complications occurring within 30 days following surgery, graded according to the Clavien-Dindo classification.
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From the date of surgery to 30 days post-surgery
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30-Day Postoperative Mortality
時間枠：From the date of surgery to 30 days post-surgery
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All-cause mortality occurring within 30 days after surgery, ascertained from medical records and follow-up data.
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From the date of surgery to 30 days post-surgery
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Unscheduled Second Surgery Rate
時間枠：From the date of surgery to 30 days post-surgery
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Rate of unscheduled reoperation within 30 days after the initial surgery, identified from surgical records and inpatient documentation.
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From the date of surgery to 30 days post-surgery
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Unplanned Return to Hospital Rate
時間枠：From the date of surgery to 30 days post-surgery
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Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery, identified from readmission records.
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From the date of surgery to 30 days post-surgery
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Operation Time
時間枠：At the time of surgery
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Total duration of the surgical procedure, extracted from operative records.
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At the time of surgery
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Intraoperative Blood Loss
時間枠：At the time of surgery
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Estimated total volume of blood loss during the surgical procedure, extracted from operative records and anesthesia documentation.
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At the time of surgery
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Postoperative Length of Stay
時間枠：From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Total number of days from the date of surgery to hospital discharge, extracted from inpatient medical records.
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From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Preoperative Endoscopic Tumor Size
時間枠：From 30 days prior to surgery to the date of surgery
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Maximum diameter of the primary tumor (in millimeters) measured by preoperative gastroscopy.
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From 30 days prior to surgery to the date of surgery
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Preoperative Endoscopic Macroscopic Type
時間枠：From 30 days prior to surgery to the date of surgery
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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.
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From 30 days prior to surgery to the date of surgery
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Preoperative CT-Determined Tumor Invasion Depth (cT)
時間枠：From 30 days prior to surgery to the date of surgery
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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.
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From 30 days prior to surgery to the date of surgery
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Preoperative CT-Determined Lymph Node Status (cN)
時間枠：From 30 days prior to surgery to the date of surgery
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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.
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From 30 days prior to surgery to the date of surgery
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Preoperative CT Suspicious Lymph Node Count
時間枠：From 30 days prior to surgery to the date of surgery
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The number of suspicious metastatic lymph nodes identified during the preoperative enhanced CT examination.
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From 30 days prior to surgery to the date of surgery
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Pathological Tumor Invasion Depth (pT)
時間枠：From date of surgery to 7 days post-surgery
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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.
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From date of surgery to 7 days post-surgery
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Pathological Lymph Node Status (pN)
時間枠：From date of surgery to 7 days post-surgery
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Pathological lymph node metastasis status assessed according to AJCC 8th edition pN category (pN0, pN1, pN2, or pN3) based on postoperative histopathological examination.
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From date of surgery to 7 days post-surgery
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Number of Lymph Nodes Examined
時間枠：From date of surgery to 7 days post-surgery
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Total number of lymph nodes retrieved and examined from the resected specimen.
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From date of surgery to 7 days post-surgery
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Number of Positive Lymph Nodes
時間枠：From date of surgery to 7 days post-surgery
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Total number of lymph nodes with pathologically confirmed metastasis.
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From date of surgery to 7 days post-surgery
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Anatomical Location of Metastatic Lymph Nodes
時間枠：From date of surgery to 7 days post-surgery
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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.
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From date of surgery to 7 days post-surgery
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Lymph Node Metastasis Rate
時間枠：From date of surgery to 7 days post-surgery
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Proportion of positive lymph nodes among total lymph nodes examined (number of positive lymph nodes / total lymph nodes examined × 100%).
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From date of surgery to 7 days post-surgery
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Histological Differentiation
時間枠：From date of surgery to 7 days post-surgery
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Histological differentiation of gastric adenocarcinoma, categorized as well-differentiated, moderately-differentiated, poorly-differentiated, or undifferentiated, based on postoperative pathology.
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From date of surgery to 7 days post-surgery
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Lymphovascular Invasion
時間枠：From date of surgery to 7 days post-surgery
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Presence or absence of lymphatic and/or vascular invasion assessed by postoperative histopathological examination.
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From date of surgery to 7 days post-surgery
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Perineural Invasion
時間枠：From date of surgery to 7 days post-surgery
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Presence or absence of perineural invasion assessed by postoperative histopathological examination.
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From date of surgery to 7 days post-surgery
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R0 Resection Rate
時間枠：From date of surgery to 7 days post-surgery
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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.
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From date of surgery to 7 days post-surgery
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Gastric Emptying Scintigraphy
時間枠：From 30 days prior to surgery to 10 years post-surgery
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It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
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From 30 days prior to surgery to 10 years post-surgery
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Helicobacter pylori Infection Status
時間枠：From 30 days prior to surgery to 10 years post-surgery
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Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
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From 30 days prior to surgery to 10 years post-surgery
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EORTC QLQ-C30
時間枠：From 30 days prior to surgery to 10 years post-surgery
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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.
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From 30 days prior to surgery to 10 years post-surgery
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EORTC QLQ-STO22
時間枠：From 30 days prior to surgery to 10 years post-surgery
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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.
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From 30 days prior to surgery to 10 years post-surgery
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PGSAS-45
時間枠：From 30 days prior to surgery to 10 years post-surgery
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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.
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From 30 days prior to surgery to 10 years post-surgery
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Serum Albumin
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Serum Total Protein
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Hemoglobin
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Prognostic Nutritional Index (PNI)
時間枠：From 30 days prior to surgery to 10 years post-surgery
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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.
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From 30 days prior to surgery to 10 years post-surgery
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Inflammatory marker
時間枠：From 30 days prior to surgery to 10 years post-surgery
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It will be measured by serum C reactive protein (CRP) level.
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From 30 days prior to surgery to 10 years post-surgery
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Carcinoembryonic Antigen (CEA)
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Carbohydrate Antigen 19-9 (CA19-9)
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Carbohydrate Antigen 72-4 (CA72-4)
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Alpha-Fetoprotein (AFP)
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Carbohydrate Antigen 125 (CA125)
時間枠：From 30 days prior to surgery to 10 years post-surgery
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From 30 days prior to surgery to 10 years post-surgery
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Time to First Flatus
時間枠：From date of surgery until date of hospital discharge, assessed up to 2 weeks
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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.
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From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Resumption of Oral Intake
時間枠：From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Time from the date of surgery to the resumption of oral intake (liquid or solid diet), extracted from postoperative dietary records.
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From date of surgery until date of hospital discharge, assessed up to 2 weeks
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Overall Hospitalization Cost
時間枠：From the time of admission to the time of discharge, assessed up to 3 weeks
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From the time of admission to the time of discharge, assessed up to 3 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月8日
一次修了 (推定)
2027年5月8日
研究の完了 (推定)
2027年6月8日
試験登録日
最初に提出
2026年7月31日
QC基準を満たした最初の提出物
2026年7月31日
最初の投稿 (実際)
2026年8月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月5日
QC基準を満たした最後の更新が送信されました
2026年7月31日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。