AI-assisted renal biopsy diagnosis
Official title: The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Image Diagnosis System.
Run by Zhujiang Hospital · NCT07330362 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 15 Years to 79 Years |
| Sex | All |
| Enrollment | 2900 (estimated) |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07330362 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.