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Recruiting NCT07124754

Multimodal Deep Learning for Lymph Node Metastasis Prediction and Physician Performance Assessment in T1 Gastric Cancer

Observational T1 Gastric Cancer Lymph Node Metastasis Early Gastric Cancer Artificial Intelligence-Assisted Diagnosis Multimodal Data Integration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in T1 Gastric Cancer.
Who it may be relevant to
Registry conditions: T1 Gastric Cancer Lymph Node Metastasis Early Gastric Cancer Artificial Intelligence-Assisted Diagnosis Multimodal Data Integration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development and Validation of a Multimodal Artificial Intelligence Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer and Its Impact on Physician Diagnostic Performance

Overview

This study aims to develop and validate an artificial intelligence (AI) model that integrates clinical, pathological, and imaging data to predict the presence of lymph node metastasis (LNM) in patients with T1-stage gastric cancer. The study will also compare the diagnostic performance of physicians with and without AI assistance, including clinicians with varying levels of experience. The goal is to improve early decision-making and support more personalized treatment strategies for patients with early gastric cancer.

Interventions

  • Diagnostic test Multimodal Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in T1 Gastric Cancer
    This intervention involves the use of a custom-built artificial intelligence (AI) diagnostic model that integrates multimodal data-including clinical variables, histopathological features, and imaging data-to predict lymph node metastasis in patients with T1-stage gastric cancer. The model provides risk probability scores and classification outputs that assist physicians in diagnostic decision-making. The AI system will be compared with physician performance at different levels of experience (

Primary outcome measures

  • Diagnostic Accuracy of the AI Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer [Time frame: Immediately after surgery (within 7 days postoperatively, based on final pathological report)]
  • Diagnostic Accuracy of the AI Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer [Time frame: At the time of final pathological diagnosis (typically within 3-7 days after surgery)]

Eligibility criteria

Inclusion criteria

Age 18 years or older

Histologically confirmed primary gastric adenocarcinoma

Clinical stage T1 (T1a or T1b) confirmed by endoscopy and imaging

Undergoing radical gastrectomy with lymph node dissection

Preoperative data available: clinical variables, CT imaging, and pathology slides

Written informed consent provided

Exclusion criteria

History of other malignancies within the past 5 years

Received neoadjuvant chemotherapy or radiotherapy

Incomplete clinical or pathological data

Poor quality or missing CT or histopathology images

Patients with distant metastasis (M1) at diagnosis

Inability or refusal to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the Fourth Hospital of Hebei Medical University — Shijiazhuang

Identifiers

NCT: NCT07124754 · GC-RAD-AI-2025-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗