Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu Cancer Institute & Hospital | OTHER |
| Zhengzhou University | OTHER |
| Peking University First Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Accurate preoperative assessment of gastric cancer stage guides eligibility for endoscopic resection, extent of gastrectomy and lymphadenectomy, selection for neoadjuvant therapy, and use of staging laparoscopy. Contrast-enhanced CT (CECT) is guideline-endorsed for initial staging, yet performance varies across institutions and readers. This study will evaluate an artificial-intelligence (AI) system that analyzes routine CECT to detect gastric cancer and assign four-class T stage (T1-T4) and N stage (N0-N3) .
Adults with confirmed gastric cancer undergoing pre-treatment CECT will be enrolled. The AI analysis will be applied to clinically acquired images. Radiologist interpretations with and without AI support will be collected in a prespecified reader study. The reference standard will include surgical pathology, supplemented by clinical follow-up when applicable. The primary outcome is detection performance, diagnostic performance of the AI for four-class staging (e.g., accuracy and area under the receiver operating characteristic curve). Secondary outcomes include the effect of AI assistance on reader accuracy and interpretation time, inter-reader agreement, and cross-site reproducibility.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Internal Derivation Cohort) | Retrospective case-only cohort of adults with pathologically confirmed gastric cancer who underwent preoperative contrast-enhanced CT at the sponsoring institution. Existing CT images and clinical/pathology records will be used to train and test the AI model and to estimate diagnostic performance for T and N staging. |
| |
| Cohort 2 (External Validation Cohort A) | Independent retrospective case-only cohort from an external hospital with the same inclusion/exclusion criteria. Used solely for external validation to assess reproducibility across sites and scanners. |
| |
| Cohort 3 (External Validation Cohort B) | A second independent retrospective validation cohort from another institution to further test generalizability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan | Diagnostic Test | preoperative contrast-enhanced CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the AI model for staging | The primary outcome is the diagnostic accuracy of the AI system for four-class T staging (T1-T4) and N staging (N0-3) based on contrast-enhanced CT. The AI performance will be assessed using accuracy, area under the receiver operating characteristic curve (AUC), and micro-AUC for internal and external cohorts. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reader Accuracy with AI Support | This outcome measures the accuracy of radiologists in classifying gastric cancer stagewhen aided by the AI system compared to manual classification without AI assistance. Accuracy will be compared between different radiologist experience levels. | 3 years |
| Survival time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
This study will enroll adult patients (≥18 years old) with a confirmed diagnosis of gastric cancer (adenocarcinoma) who have undergone contrast-enhanced CT (CECT) as part of their standard preoperative evaluation. Participants will be selected from both internal and external cohorts, with inclusion from multiple centers to assess cross-site reproducibility and generalizability of the AI model.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Yudong, PHD, MD | Contact | +8618251966069 | zhangyd3895@njmu.edu.cn | |
| Qiong Li | Contact | +8618351977281 | njmu_lq@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Yudong | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Calculate the survival time of gastric cancer patients from the point of diagnosis and treatment initiation. |
| 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |