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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of the AI Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Diagnostic Accuracy of the AI Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer
时间窗: At the time of final pathological diagnosis (typically within 3-7 days after surgery)
次要结局
未报告次要终点
研究者
Qun Zhao
Professor
Hebei Medical University