Multimodal Deep Learning for Lymph Node Metastasis Prediction and Physician Performance Assessment in T1 Gastric Cancer
NCT ID: NCT07124754
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-01-01
2025-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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 (resident, attending, senior) to assess its impact on diagnostic accuracy and clinical decision support.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Qun Zhao
OTHER
Responsible Party
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Qun Zhao
Professor
Locations
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the Fourth Hospital of Hebei Medical University
Shijiazhuang, None Selected, China
Countries
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Facility Contacts
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Other Identifiers
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GC-RAD-AI-2025-04
Identifier Type: -
Identifier Source: org_study_id
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