Gastric cancer
Conditions
Interventions
Gold Standard:Postoperative pathological pTNM staging
Index test:Preoperative AI cTNM staging and clinical doctor's cTNM staging
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age/Gender: 18 - 80 years old, gender not restricted. 2. Diagnosis: Confirmed as gastric adenocarcinoma through gastroscopy biopsy and pathological examination. 3. Treatment plan: After multidisciplinary discussion (MDT), a radical gastrectomy is planned, and D2 lymph node dissection is scheduled (the specific surgical method will be determined by the clinical team according to routine procedures). 4. Examination and time window: Before the radical surgery, complete the routine procedures of enhanced CT and gastroscopy at this center, and meet the following requirements: (1) Time window from imaging examination to surgery: <= 14 days (if the time window is exceeded due to clinical reasons, the reason must be recorded and can be included in descriptive/sensitivity analysis); (2) CT includes at least the portal venous phase (if the center's routine includes arterial phase/balanced phase, record the phase as usual); (3) Gastroscopy images/videos can be traced and exported in the hospital system for research analysis. 5. Image availability (minimum quality requirements): (1) CT has no severe motion artifacts, contrast agent injection failure, or missing key phases; (2) Gastroscopy images have no severe blurriness/overly bleeding that obscures the lesion and makes it impossible to interpret; (3) Image quality is judged as "assessable" by the research-predefined quality control standards: (4) Qualified CT and gastroscopy images; (5) AI successfully outputs and locks; (6) Doctors complete cTNM records; (7) Radical resection is completed and complete pathological pT/pN are obtained. 6. Ethical requirements: The subject or their legal representative signs the informed consent form and is willing to cooperate with the research process and data usage.
Exclusion criteria
Exclusion criteria: 1. Previous anti-tumor treatment: Those who received neoadjuvant chemotherapy, radiotherapy, immunotherapy or targeted therapy for this gastric cancer before the surgery. 2. Previous history of gastric surgery: Those who had undergone gastric resection, gastric bypass or other surgeries that significantly altered the anatomical structure of the stomach (which may affect imaging anatomy and AI recognition). 3. Coexisting other malignant tumors: Those who had concurrent active malignant tumors, or whose previous malignant tumors had recurred or metastasized within the past 5 years. 4. Unable to undergo radical resection: Those who were unable to undergo radical resection due to distant metastasis or extensive peritoneal dissemination discovered during the surgery (such cases generally cannot obtain comparable "post-radical resection pTNM" and will be treated as screening exclusion or unassessable). 5. Missing key data or unidentifiable reference standards: Postoperative pathological data is incomplete, making it impossible to determine pT or pN (or unable to form pTNM according to the preset standards); or key lymph node information is missing, resulting in the inability to determine the stage. 6. Unavailable or unassessable imaging data: (1) Preoperative CT or gastroscopy images cannot be obtained, lost, or failed to be de-identified; (2) The imaging quality is severely substandard, and is judged as "unassessable" according to the preset quality control standards. 7. Other situations considered inappropriate for inclusion by the researchers: Such as situations that affect compliance or data integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Positive predictive value;Negative predictive value;F1 value;Area under the ROC curve;Consistency;Stability; | — |
Countries
China
Contacts
Public ContactChao Yan
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed