Chronic GlomerulonephritisNCT07330362
The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Diagnosis System.
An observational study of Chronic Glomerulonephritis and Chronic Kidney Disease, run by Zhujiang Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 79 years
- Conditions the study is for
- Chronic Glomerulonephritis, Chronic Kidney Disease
- How many people
- 2,900 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For patients with chronic kidney disease who need further diagnosis through renal biopsy.
Who may be able to join
- 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.
Who cannot join
- Biopsy tissue from donor kidney or transplanted kidney;
- Poor quality of pathological specimen, unable to conduct pathological diagnosis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
Li Liang, 15989146266, lli@smu.edu.com
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Yangshu Zhou, 020-61643888, 764709402@qq.com
About this study
Official title: The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Image Diagnosis System.
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.
Read the 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.
- Conditions
- Chronic Glomerulonephritis, Chronic Kidney Disease
- Keywords
- Artificial intelligence, TEM-AID, glomerulonephritis
- Medical subject headings
- Renal Insufficiency, Chronic, Glomerulonephritis
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model for candidates will be calculated.
Measured: baseline
Secondary outcomes (2)
The specificity of the TEM-AID artificial intelligence model.
The specificity of the TEM-AID artificial intelligence model for candidates will be calculated.
Measured: baseline
The sensitivity of the TEM-AID artificial intelligence model.
The sensitivity of the TEM-AID artificial intelligence model for candidates will be calculated.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330362
- Sponsor's protocol ID
- 2024BA0045_GC
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Artificial Intelligence Assisted Renal Biopsy Image Diagnosis System.
- ClinicalTrials.gov ID
- NCT07330362
- Acronym / sponsor ID
- 2024BA0045_GC
- Conditions
- Chronic Glomerulonephritis, Chronic Kidney Disease
- Keywords
- Artificial intelligence, TEM-AID, glomerulonephritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For patients with chronic kidney disease who need further diagnosis through renal biopsy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Biopsy tissue from donor kidney or transplanted kidney;
- Poor quality of pathological specimen, unable to conduct pathological diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model
Time frame: baseline
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model for candidates will be calculated.
2 secondary outcomes
The specificity of the TEM-AID artificial intelligence model.
Time frame: baseline
The sensitivity of the TEM-AID artificial intelligence model.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Glomerulonephritis and Chronic Kidney Disease, run by Zhujiang Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yangshu Zhou (020-61643888, 764709402@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the TEM-AID artificial intelligence model (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.