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NCT Number: NCT07747688

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Zhi Zheng, Attending surgon

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical data collection

Other

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

Primary outcomes

  1. Disease-Free Survival

    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.

Secondary outcomes

  1. Overall Survival

    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.

  2. Recurrence-Free Survival

    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.

  3. Progression-Free Survival

    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.

  4. 30-Day Postoperative Complications

    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.

  5. 30-Day Postoperative Mortality

    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.

  6. Unscheduled Second Surgery Rate

    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.

  7. Unplanned Return to Hospital Rate

    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.

  8. Operation Time

    Time frame: At the time of surgery

    Total duration of the surgical procedure, extracted from operative records.

  9. Intraoperative Blood Loss

    Time frame: At the time of surgery

    Estimated total volume of blood loss during the surgical procedure, extracted from operative records and anesthesia documentation.

  10. Postoperative Length of Stay

    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.

  11. Preoperative Endoscopic Tumor Size

    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.

  12. Preoperative Endoscopic Macroscopic Type

    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.

  13. Preoperative CT-Determined Tumor Invasion Depth (cT)

    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.

  14. Preoperative CT-Determined Lymph Node Status (cN)

    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.

  15. Preoperative CT Suspicious Lymph Node Count

    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.

  16. Pathological Tumor Invasion Depth (pT)

    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.

  17. Pathological Lymph Node Status (pN)

    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.

  18. Number of Lymph Nodes Examined

    Time frame: From date of surgery to 7 days post-surgery

    Total number of lymph nodes retrieved and examined from the resected specimen.

  19. Number of Positive Lymph Nodes

    Time frame: From date of surgery to 7 days post-surgery

    Total number of lymph nodes with pathologically confirmed metastasis.

  20. Anatomical Location of Metastatic Lymph Nodes

    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.

  21. Lymph Node Metastasis Rate

    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%).

  22. Histological Differentiation

    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.

  23. Lymphovascular Invasion

    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.

  24. Perineural Invasion

    Time frame: From date of surgery to 7 days post-surgery

    Presence or absence of perineural invasion assessed by postoperative histopathological examination.

  25. R0 Resection Rate

    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.

  26. Gastric Emptying Scintigraphy

    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.

  27. Helicobacter pylori Infection Status

    Time frame: From 30 days prior to surgery to 10 years post-surgery

    Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.

  28. EORTC QLQ-C30

    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.

  29. EORTC QLQ-STO22

    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.

  30. PGSAS-45

    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.

  31. Serum Albumin

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  32. Serum Total Protein

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  33. Hemoglobin

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  34. Prognostic Nutritional Index (PNI)

    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.

  35. Inflammatory marker

    Time frame: From 30 days prior to surgery to 10 years post-surgery

    It will be measured by serum C reactive protein (CRP) level.

  36. Carcinoembryonic Antigen (CEA)

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  37. Carbohydrate Antigen 19-9 (CA19-9)

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  38. Carbohydrate Antigen 72-4 (CA72-4)

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  39. Alpha-Fetoprotein (AFP)

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  40. Carbohydrate Antigen 125 (CA125)

    Time frame: From 30 days prior to surgery to 10 years post-surgery

  41. Time to First Flatus

    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.

  42. Resumption of Oral Intake

    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.

  43. Overall Hospitalization Cost

    Time frame: From the time of admission to the time of discharge, assessed up to 3 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi Zheng, Attending surgon

CONTACT

[email protected]

+86-13811132175

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

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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