Ireland
--:--IST
Recruiting Observational

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

NCT07330362 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-07-01
Last updated
2026-01-27

Condition(s) studied

Chronic GlomerulonephritisChronic Kidney Disease

Study 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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
79 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model — baseline
    The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model for candidates will be calculated.

Trial sites (2)

FacilityCityRegionStatus
Nanfang Hospital Guangzhou Guangdong Recruiting
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07330362 on ClinicalTrials.gov ↗ ← All trials in China