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Active, not recruiting Observational

Model Development and Application Based on Renal Pathology Images

NCT07816874 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2019-01-01
Last updated
2026-09-14

Condition(s) studied

Kidney Diseases, ChronicGlomerular DiseasesTubulointerstitial Kidney DiseasesIgA Nephropathy (IgAN)Membranous Nephropathy

Study summary

This single-center retrospective observational cohort study will utilize digital renal pathology images along with corresponding clinical and laboratory data from patients who underwent kidney biopsy at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, between January 1, 2019, and March 31, 2026. Deep learning and image analysis techniques will be employed to develop and validate models for the pathological diagnosis and classification of kidney diseases. The study will also assess model performance in evaluating disease activity and chronicity, as well as investigate the association between image-derived features and long-term renal outcomes. Diagnoses will be established by consensus among three senior renal pathologists, who will serve as the reference standard. A minimum of 8,000 eligible cases are planned for inclusion, which will be divided into training, validation, and independent test sets.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients with kidney disease confirmed by kidney biopsy. 2. Availability of complete digital renal pathology images, including light microscopy, immunofluorescence microscopy, and/or electron microscopy images, as required for the relevant diagnostic task. 3. Availability of the clinical and laboratory data required for the planned analyses. Exclusion Criteria: 1. Renal pathology images of insufficient quality for analysis. 2. Missing key clinical data required for the planned analyses. 3. Kidney allograft biopsy specimens.

Primary outcome measure(s)

  • Diagnostic classification accuracy of the deep learning model, measured as the percentage of correctly classified renal pathology cases — At completion of independent test-set evaluation using retrospective data collected from January 1, 2019, through March 31, 2026.
    Diagnostic classification accuracy will be assessed in the independent test set by comparing the renal disease classification predicted by the prespecified deep learning model with the consensus diagnosis established by three senior renal pathologists. Accuracy will be calculated as the number of correctly classified cases divided by the total number of evaluable cases and reported as a percentage (%). The measurement tool will be the prespecified deep learning model evaluated against the expert consensus reference standard.

Trial sites (1)

FacilityCityRegionStatus
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
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 NCT07816874 on ClinicalTrials.gov ↗ ← All trials in China