The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Image Diagnosis System.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,900
- 试验地点
- 2
- 主要终点
- The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model
研究概览
简要总结
This research project aims to collect images from patients with chronic glomerulonephritis. For each subject, the images obtained from renal biopsy will undergo evaluation by both the diagnostic model and the 'gold standard' diagnosis by pathologists. The researchers will test the subjects using the diagnostic model and compare the results with the known 'gold standard' diagnosis, in order to evaluate the AUC, specificity, and sensitivity of the diagnostic model.
详细描述
Renal biopsy pathology is an essential gold standard for the diagnosis of most glomerular diseases, relying on the comprehensive evaluation of H&E staining, special stains (such as PAS, PASM, and Masson), immunofluorescence, and the ultrastructural study under transmission electron microscopy (TEM). This research project aims to collect images from patients with chronic glomerulonephritis. For each subject, the images obtained from renal biopsy will undergo evaluation by both the diagnostic model and the 'gold standard' diagnosis by pathologists. The researchers will test the subjects using the diagnostic model and compare the results with the known 'gold standard' diagnosis, in order to evaluate the AUC, specificity, and sensitivity of the diagnostic model.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signing of informed consent form;
- •Patients clinically diagnosed or suspected of having chronic kidney disease according to the 2023 KDIGO Clinical Practice Guideline for the Evaluation and Management of Kidney Disease;
- •Undergoing renal biopsy and pathological specimen preparation.
排除标准
- •Biopsy tissue from donor kidney or transplanted kidney;
- •Poor quality of pathological specimen, unable to conduct pathological diagnosis.
结局指标
主要结局
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model
时间窗: baseline
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model for candidates will be calculated.
次要结局
- The specificity of the TEM-AID artificial intelligence model.(baseline)
- The sensitivity of the TEM-AID artificial intelligence model.(baseline)