ClinicalTrials.gg
Active, not recruitingNCT07816874Updated Sep 14, 2026

Model Development and Application Based on Renal Pathology Images

An observational study in Kidney Diseases, Chronic, Glomerular Diseases and Tubulointerstitial Kidney Diseases, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 245 studies in Renal Insufficiency, Chronic with a site in China — 94 open to participants now, 107 under way, 17 of them phase 3. Renal Insufficiency, Chronic · China.

Enrollment
18th of 80
8,000 · median 1,350
Started
2019
with 9 others
Observational
80 of 245
40 open now
Primary completion
2026-03
later than 28 of 106 live
Registered
242nd of 245
by date

Among the 245 studies in Renal Insufficiency, Chronic with a site in China, this one is the 18th largest by enrollment of the 80 observational ones that give a count, is one of 10 that started in 2019, is one of 80 observational ones, reaches primary completion later than 28 of the 106 other live ones, and was the 242nd registered.

Renal Insufficiency, Chronic

3,094 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.

Browse Renal Insufficiency, Chronic studies →

Open to participants now

94 of the 245 studies in Renal Insufficiency, Chronic with a site in China are open now. Recruiting first, the newest first:

89 more — sign in →

All 94 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 434 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.

This study: all sexes.

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02

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.

03

Conditions studied

  • Kidney Diseases, Chronic
  • Glomerular Diseases
  • Tubulointerstitial Kidney Diseases
  • IgA Nephropathy (IgAN)
  • Membranous Nephropathy
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population will comprise patients who underwent native kidney biopsy at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, between January 1, 2019, and March 31, 2026. Eligible cases will be retrospectively identified from the hospital's electronic medical record and pathology image systems. Patients with biopsy-confirmed kidney diseases and available digital renal pathology images and corresponding clinical and laboratory data will be included for model development and validation. Kidney allograft biopsy cases will not be included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with kidney disease confirmed by kidney .
  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

Exclusion Criteria:

  1. Renal pathology images of insufficient quality for analysis.
  2. Missing key clinical data required for the planned analyses.
  3. Kidney allograft specimens.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8,000 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Diagnostic classification accuracy of the deep learning model, measured as the percentage of correctly classified renal pathology cases

    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.

    Time frame: At completion of independent test-set evaluation using retrospective data collected from January 1, 2019, through March 31, 2026.

Secondary outcomes

  1. Agreement between deep learning model predictions and expert consensus diagnoses, measured by the Cohen kappa coefficient

    Agreement between the renal disease classifications generated by the prespecified deep learning model and the consensus diagnoses established by three senior renal pathologists will be assessed using the Cohen kappa coefficient. The measurement tool will be a prespecified categorical agreement analysis comparing model-predicted classifications with the expert consensus reference standard. The Cohen kappa coefficient is a unitless measure, with higher values indicating greater agreement beyond chance.

    Time frame: At completion of independent test-set evaluation using retrospective data collected from January 1, 2019, through March 31, 2026.

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Mar 2026, 86 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2026
First posted
Sep 14, 2026
StartActual
Jan 1, 2019
Primary completionActual
Mar 31, 2026
CompletionEst.
May 10, 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07816874
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Jan 1, 2019
Primary completion
Mar 31, 2026
Completion
May 10, 2027 (estimated)
Last update
Sep 14, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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