NCT07330362

The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Diagnosis System.

The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Image Diagnosis System.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,900 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Glomerulonephritis
• Chronic Kidney Disease

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-09
• Last updated: 2026-01-27

Locations

2 sites across 1 country: China