AI-assisted renal biopsy diagnosis
The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Image Diagnosis System.
This project tests an artificial intelligence tool that looks at kidney biopsy images to see if it can accurately diagnose chronic glomerulonephritis and chronic kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2900 (estimated) |
| Ages | 15 Years to 79 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT07330362 on ClinicalTrials.gov |
What this trial studies
Researchers will collect light microscopy, special stain, immunofluorescence, and transmission electron microscopy images from patients undergoing renal biopsy for chronic glomerulonephritis. An artificial intelligence diagnostic model will analyze these images and its outputs will be compared to the pathologists' gold-standard diagnoses. The study will report performance metrics such as area under the curve (AUC), sensitivity, and specificity. This is an observational comparison of model results versus standard pathological interpretation at two Guangzhou hospitals.
Who should consider this trial
Good fit: Ideal candidates are patients who consent to participate, meet 2023 KDIGO criteria for suspected or diagnosed chronic kidney disease or chronic glomerulonephritis, and are undergoing renal biopsy at the study sites.
Not a fit: Patients with donor or transplanted kidney biopsy tissue, those with poor-quality pathological specimens, or people not undergoing a renal biopsy are not eligible and would not benefit from this specific project.
Why it matters
Potential benefit: If successful, the AI tool could speed up and standardize biopsy interpretation, supporting earlier and more consistent diagnoses for patients with glomerular disease.
How similar studies have performed: Related AI approaches for pathology and kidney biopsy image analysis have shown promising results in research settings but are not yet established as standard clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary signing of informed consent form; 2. 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; 3. Undergoing renal biopsy and pathological specimen preparation. Exclusion Criteria: 1. Biopsy tissue from donor kidney or transplanted kidney; 2. Poor quality of pathological specimen, unable to conduct pathological diagnosis.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yangshu Zhou
- Email: 764709402@qq.com
- Phone: 020-61643888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.