Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer: A Multicenter, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
This nationwide, multicenter observational study aims to develop and validate a multimodal artificial intelligence (AI) model for detecting occult lymph node metastasis in early-stage non-small cell lung cancer (NSCLC) patients. Despite advances in lymph node staging, 12.9%-39.3% of occult nodal metastasis cases remain undetected preoperatively, affecting treatment decisions. This study will use deep learning to extract imaging features of occult metastasis and combine them with clinical data to build an AI model for risk prediction. This study will provide insights into the feasibility of AI-driven detection of occult metastasis, supporting clinical decision-making and potentially revealing underlying biological mechanisms of lymph node metastasis in NSCLC.
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
- •Pathologically confirmed non-small cell lung cancer;
- •Clinical stage I (AJCC, 8th edition, 2017);
- •Age≥18 years old;
- •KPS score≥70;
- •Patients who have undergone primary NSCLC radical surgery or SBRT treatment;
- •Complete systemic lesion imaging assessment before primary NSCLC radical surgery or SBRT treatment (Note: Tumor size ≥ 3 cm or centrally located tumor requires PET/CT and/or invasive mediastinal staging);
- •Patients willing to cooperate with the follow-up after primary NSCLC radical surgery;
- •informed consent of the patient.
排除标准
- •Poor quality of computed tomography imaging;
- •Baseline imaging shows pure ground-glass nodules (GGO);
- •Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
- •Loss to follow-up.
结局指标
主要结局
Recurrence-free survival (RFS)
时间窗: 1 year
The time from surgical treatment or SBRT to disease recurrence or death. Patients who were still not progressing at the time of analysis will have the date of their last contact as the cutoff date.
次要结局
- Overall Survival (OS)(1 year)