ClinicalTrials.gg
Status unknownNCT05797051Updated May 3, 2023

Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases

An observational study in Glomerulonephritis, IGA, Glomerulonephritis, Membranous and Diabetic Nephropathies, sponsored by Qianfoshan Hospital. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Qianfoshan Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
80
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Glomerulonephritis, IGA
  • Glomerulonephritis, Membranous
  • Diabetic Nephropathies
  • Nephrosis, Lipoid
  • Hyperspectral Imaging
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 80 is below the median of 245 across 45 observational studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with massive proteinuria were diagnosed as IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy by renal biopsy.

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

  • Over 18 years old;
  • Patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, minimal change nephropathy confirmed by renal ;
  • Had not received hormone and/or 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    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.

    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.

    Diagnostic Test: Microscopic hyperspectral imaging system

Interventions

  • Diagnostic testMicroscopic hyperspectral imaging system

    Microscopic hyperspectral imaging system

06

What researchers measure

Primary outcomes

  1. Microhyperspectral image of urine specimen

    Microhyperspectral images of urine samples from patients with four different glomerular diseases before treatment

    Time frame: 2023.4-2023.10

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2023; primary completion for Aug 2023, 2 months later.

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

Registered
Mar 18, 2023
First posted
Apr 4, 2023
StartEst.
May 30, 2023
Primary completionEst.
Aug 20, 2023
CompletionEst.
Sep 20, 2023
Last update
May 3, 2023
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 May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05797051
Responsible party
Zunsong Wang (Qianfo Mountain Hospital of Shandong Province, Qianfoshan Hospital) — Principal investigator
First posted
Apr 4, 2023
Start date
May 30, 2023 (estimated)
Primary completion
Aug 20, 2023 (estimated)
Completion
Sep 20, 2023 (estimated)
Last update
May 3, 2023

Study contacts

Wang Zongsong
Contact
wzsong3@163.com
18660190175

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion