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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qun Zhao

OTHER

Sponsor Role lead

Responsible Party

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Qun Zhao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the Fourth Hospital of Hebei Medical University

Shijiazhuang, None Selected, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ping'an Ding

Role: primary

031186095363

Other Identifiers

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GC-RAD-AI-2025-04

Identifier Type: -

Identifier Source: org_study_id

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