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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.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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.

Zhi Zheng, Attending surgon contact

+86-13811132175

zhengzhi@ccmu.edu.cn

China1 site, 1 recruiting
  • Beijing Friendship Hospital, Capital Medical University

    Beijing

    Zhi Zheng, Attending surgon, zhengzhi@ccmu.edu.cn

    Recruiting

Other trials in China

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.

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 groups in NCT07747688
Study groupRoleWhat they receive
Early Gastric Cancer CohortA 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Operation Time

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

    Measured: At the time of surgery

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Number of Positive Lymph Nodes

    Total number of lymph nodes with pathologically confirmed metastasis.

    Measured: From date of surgery to 7 days post-surgery

  20. 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

  21. 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

  22. 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

  23. 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

  24. Perineural Invasion

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

    Measured: From date of surgery to 7 days post-surgery

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. Serum Albumin

    Measured: From 30 days prior to surgery to 10 years post-surgery

  32. Serum Total Protein

    Measured: From 30 days prior to surgery to 10 years post-surgery

  33. Hemoglobin

    Measured: From 30 days prior to surgery to 10 years post-surgery

  34. 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

  35. 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

  36. Carcinoembryonic Antigen (CEA)

    Measured: From 30 days prior to surgery to 10 years post-surgery

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

    Measured: From 30 days prior to surgery to 10 years post-surgery

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

    Measured: From 30 days prior to surgery to 10 years post-surgery

  39. Alpha-Fetoprotein (AFP)

    Measured: From 30 days prior to surgery to 10 years post-surgery

  40. Carbohydrate Antigen 125 (CA125)

    Measured: From 30 days prior to surgery to 10 years post-surgery

  41. 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

  42. 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

  43. 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.

  1. First posted5 Aug 2026
  2. Study start8 May 2026
  3. Primary completion8 May 2027 (estimated)
  4. Study completion8 Jun 2027 (estimated)

Resources

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)
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

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