The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Diagnosis System.
Recruiting · NCT07330362 · Observational (researchers observe without assigning treatment) · Lead sponsor: Zhujiang Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
15 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Voluntary signing of informed consent form;
- 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;
- Undergoing renal biopsy and pathological specimen preparation.
Exclusion criteria
- Biopsy tissue from donor kidney or transplanted kidney;
- Poor quality of pathological specimen, unable to conduct pathological diagnosis.
Where it is running
2 locations listed.
- Nanfang Hospital - Guangzhou, Guangdong, China
- Zhujiang Hospital of Southern Medical University - Guangzhou, Guangdong, China