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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07330362
Enrollment
2900
Registered
2026-01-09
Start date
2024-07-01
Completion date
2026-12-31
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Glomerulonephritis, Chronic Kidney Disease

Keywords

Artificial intelligence, TEM-AID, glomerulonephritis

Brief 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.

Interventions

None listed

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
The specificity of the TEM-AID artificial intelligence model.baselineThe specificity of the TEM-AID artificial intelligence model for candidates will be calculated.
The sensitivity of the TEM-AID artificial intelligence model.baselineThe sensitivity of the TEM-AID artificial intelligence model for candidates will be calculated.

Countries

China

Contacts

CONTACTYangshu Zhou
764709402@qq.com020-61643888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026