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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05797051
Other study ID # liquid biopsy-glomerulopathy
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 30, 2023
Est. completion date September 20, 2023

Study information

Verified date April 2023
Source Qianfoshan Hospital
Contact Wang Zongsong
Phone 18660190175
Email wzsong3@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 20, 2023
Est. primary completion date August 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 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. 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.

Study Design


Intervention

Diagnostic Test:
Microscopic hyperspectral imaging system
Microscopic hyperspectral imaging system

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qianfoshan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Microhyperspectral image of urine specimen Microhyperspectral images of urine samples from patients with four different glomerular diseases before treatment 2023.4-2023.10
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