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| Name | Class |
|---|---|
| Renmin Hospital of Wuhan University | OTHER |
| Nanjing University School of Medicine | OTHER |
| Baoding First Central Hospital | OTHER |
| Hengshui People's Hospital |
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This study aims to develop and validate an artificial intelligence (AI) system that can predict whether lymph node metastasis has occurred in patients with gastric cancer before surgery. Using preoperative imaging and pathology data, the AI models will not only predict if metastasis is present but also identify which specific lymph node stations or individual lymph nodes are involved. All lymph nodes will be carefully removed during surgery and examined one by one with detailed pathological methods to ensure accurate diagnosis. The goal is to improve the accuracy of lymph node assessment and assist doctors in making better treatment decisions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence-Based Predictive Model for Lymph Node Metastasis | Diagnostic Test | The intervention is an artificial intelligence-based predictive model developed using preoperative multimodal data, including contrast-enhanced CT images, preoperative histopathological findings, and clinical features. The model is designed to predict (1) the presence or absence of lymph node metastasis, (2) the specific lymph node stations involved, and (3) the individual lymph nodes involved. Each lymph node's metastatic status is confirmed by serial pathological sectioning of surgically retrieved nodes, ensuring a highly accurate reference standard for model training and validation. This distinguishes the intervention from traditional imaging-based assessments and from other AI models that do not use individually validated lymph node pathology. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of the AI Model in Predicting Presence of Lymph Node Metastasis in Gastric Cancer | From Preoperative Evaluation to Completion of Postoperative Pathological Analysis (Approximately 4-6 Weeks) |
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Inclusion Criteria:
Histologically confirmed gastric adenocarcinoma
Scheduled for curative-intent gastrectomy with lymphadenectomy
Completed preoperative imaging with contrast-enhanced CT or MRI
Available preoperative biopsy pathology report
Able and willing to provide written informed consent
Exclusion Criteria:
Prior chemotherapy, radiotherapy, or major abdominal surgery
Severe comorbidities contraindicating surgery
Incomplete or poor-quality preoperative imaging or pathology data
Pregnancy or lactation
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The study will enroll adult patients diagnosed with gastric adenocarcinoma who are scheduled to undergo curative-intent gastrectomy with lymphadenectomy. Participants must have completed preoperative imaging studies and histopathological evaluation. All enrolled patients will have individually retrieved lymph nodes evaluated by detailed pathological examination to provide a definitive reference for lymph node metastasis status.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Fourth Hospital of Hebei Medical University | Shijiazhuang | None Selected | 050011 | China |
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| OTHER |
| No.1 Hospital of Shijiazhuang City | UNKNOWN |
| The Second Affiliated Hospital of Xingtai Medical College | UNKNOWN |
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| ID | Term |
|---|---|
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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