AI-Based Prediction of Lymph Node Metastasis in Gastric Cancer Using Preoperative Multimodal Data
NCT ID: NCT06957678
Last Updated: 2025-05-04
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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ENROLLING_BY_INVITATION
1200 participants
OBSERVATIONAL
2025-01-01
2025-12-31
Brief Summary
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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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Artificial Intelligence-Based Predictive Model for Lymph Node Metastasis
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.
Eligibility Criteria
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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
18 Years
80 Years
ALL
No
Sponsors
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Renmin Hospital of Wuhan University
OTHER
Nanjing University School of Medicine
OTHER
Baoding First Central Hospital
OTHER
Hengshui People's Hospital
OTHER
No.1 Hospital of Shijiazhuang City
UNKNOWN
The Second Affiliated Hospital of Xingtai Medical College
UNKNOWN
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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Other Identifiers
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GC-RAD-AI-2025-02
Identifier Type: -
Identifier Source: org_study_id
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