Clinical trial Recruiting at 2 sites Observational Ages 15 to 79

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 typeObservational
Ages15 Years to 79 Years
SexAll
Enrollment2900 (estimated)
SponsorZhujiang Hospital
Academic / other
Locations2 sites (Guangzhou, Guangdong and 1 other locations)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJanuary 27, 2026
Trial IDNCT07330362 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.