Glomerulonephritis, IGANCT05797051
Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases
An observational study of Glomerulonephritis, IGA and Glomerulonephritis, Membranous, run by Qianfoshan Hospital.
Trial summary
Morning urine samples of patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and minimal degenerative nephropathy confirmed by renal needle biopsy in our hospital from November 2020 to January 2022 were collected. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glomerulonephritis, IGA, Glomerulonephritis, Membranous, Diabetic Nephropathies
- What is being tested?
- Microscopic hyperspectral imaging system
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2023to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with massive proteinuria were diagnosed as IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy by renal biopsy.
Who may be able to join
- Over 18 years old;
- Patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, minimal change nephropathy confirmed by renal biopsy;
- Had not received hormone and/or immunosuppressive therapy before renal biopsy;
- Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.
Who cannot join
- There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc.;
- Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
- Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
- Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
- Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc., suggesting the possibility of tumor.
Trial locations and contacts
No sites are listed yet.
About this study
Morning urine samples of patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and minimal degenerative nephropathy confirmed by renal needle biopsy in our hospital from November 2020 to January 2022 were collected. By scanning the morning urine samples of corresponding patients with microhyperspectral imager, machine learning and deep learning were used to classify microhyperspectral images, and the classification accuracy was greater than 85%. Thus, hyperspectral imaging technology could be used as a non-invasive diagnostic means to assist the diagnosis of glomerular diseases.
- Conditions
- Glomerulonephritis, IGA, Glomerulonephritis, Membranous, Diabetic Nephropathies, Nephrosis, Lipoid, Hyperspectral Imaging
- Being tested
- Microscopic hyperspectral imaging system
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulonephritis, Membranous, Diabetic Nephropathies, Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic hyperspectral imaging systemDiagnostic test
Microscopic hyperspectral imaging system
| Study group | Role | What they receive |
|---|---|---|
| diabetic nephropathy | Urine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. Receives: Diagnostic Test: Microscopic hyperspectral imaging system | |
| minimal change nephropathy | Urine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. Receives: Diagnostic Test: Microscopic hyperspectral imaging system | |
| IgA nephropathy | Urine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. Receives: Diagnostic Test: Microscopic hyperspectral imaging system | |
| idiopathic membranous nephropathy | Urine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. Receives: Diagnostic Test: Microscopic hyperspectral imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microhyperspectral image of urine specimen
Microhyperspectral images of urine samples from patients with four different glomerular diseases before treatment
Measured: 2023.4-2023.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start30 May 2023 (estimated)
- Primary completion20 Aug 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, IGAStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zunsong Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797051
- Sponsor's protocol ID
- liquid biopsy-glomerulopathy
- Status last verified
- Apr 2023
- First submitted
- 18 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases
- ClinicalTrials.gov ID
- NCT05797051
- Acronym / sponsor ID
- liquid biopsy-glomerulopathy
- Conditions
- Glomerulonephritis, IGA, Glomerulonephritis, Membranous, Diabetic Nephropathies, Nephrosis, Lipoid, Hyperspectral Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 4 Apr 2023 (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.
Morning urine samples of patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and minimal degenerative nephropathy confirmed by renal needle biopsy in our hospital from November 2020 to January 2022 were collected. By scanning the morning urine samples of corresponding patients with microhyperspectral imager, machine learning and deep learning were used to classify microhyperspectral images, and the classification accuracy was greater than 85%. Thus, hyperspectral imaging technology could be used as a non-invasive diagnostic means to assist the diagnosis of glomerular diseases.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diabetic nephropathy | – | Diagnostic Test: Microscopic hyperspectral imaging systemUrine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. |
| minimal change nephropathy | – | Diagnostic Test: Microscopic hyperspectral imaging systemUrine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. |
| IgA nephropathy | – | Diagnostic Test: Microscopic hyperspectral imaging systemUrine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. |
| idiopathic membranous nephropathy | – | Diagnostic Test: Microscopic hyperspectral imaging systemUrine samples were collected from patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy. The samples were centrifuged and frozen in a refrigerator at -80 degrees Celsius. The images were divided into a training set and a test set at a fixed ratio. The digital images were input into classification models such as one-dimensional convolutional neural network to learn and test. The training set was used for the training and parameter iteration of the artificial intelligence non-invasive fluid diagnosis model, and the test set was used for the recognition and interpretation of the model. The confusion matrix, accuracy and ROC curve were calculated through the interpretation results to evaluate the performance of the model. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with massive proteinuria were diagnosed as IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy by renal biopsy.
Key inclusion criteria (4 listed)
- Over 18 years old;
- Patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, minimal change nephropathy confirmed by renal biopsy;
- Had not received hormone and/or immunosuppressive therapy before renal biopsy;
- Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.
Key exclusion criteria (5 listed)
- There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc.;
- Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
- Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
- Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
- Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc., suggesting the possibility of tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microscopic hyperspectral imaging systemMicroscopic hyperspectral imaging system | Diagnostic test | IgA nephropathy, diabetic nephropathy, idiopathic membranous nephropathy, minimal change nephropathy |
Primary outcome
Microhyperspectral image of urine specimen
Time frame: 2023.4-2023.10
Microhyperspectral images of urine samples from patients with four different glomerular diseases before treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerulonephritis, IGA and Glomerulonephritis, Membranous, run by Qianfoshan Hospital.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Zongsong (18660190175, wzsong3@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microhyperspectral image of urine specimen (time frame: 2023.4-2023.10). 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 3 May 2023.