Raman Spectroscopy Diagnosis of Kidney Diseases

NCT ID: NCT06760845

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-07-31

Brief Summary

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This research plan, from January 2021 to December 2024, aims to collect serum and morning urine from patients diagnosed with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and focal segmental glomerulosclerosis the Nephrology Department of Qianfoshan Hospital in Shandong Province, through renal biopsy. These samples will be scanned using a Raman spect to obtain Raman spectral data. The scattering peaks in the Raman spectra will be analyzed using Origin software for Gaussian curve fitting. The position of the peaks will used to query relevant literature to identify the corresponding chemical bonds and confirm the presence of compounds.

The intensity and area of the chemical substance peaks in the Raman will be calculated and used to plot calibration curves, thereby establishing a quantitative analysis equation. This equation will be used to accurately calculate the concentration of each analyte in serum and urine samples. Based on the average concentration data for each patient group, multivariate analysis methods, such as principal component analysis (PCA) and Mahalanis distance discriminant model, will be used to classify and predict the disease types.

The preliminary data for this study comes from the Nephrology Department ofianfoshan Hospital, where different types of glomerular diseases have been pathologically classified using tools such as light microscopy, electron microscopy, and immunoforescence microscopy. By combining Raman spectroscopy technology and statistical analysis, this study aims to establish a non-invasive and efficient diagnostic tool to assist in the of kidney diseases and predict treatment outcomes.

Detailed Description

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Conditions

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IgA Nephropathy (IgAN) Membranous Nephropathy Diabetic Nephropathy Focal Segmental Glomerulosclerosis (FSGS)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Imaging Time

Raman spectroscopy images of blood and urine

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older;
2. Patients diagnosed with IgA nephropathy, idiopathic membranous nephrop, diabetic nephropathy, or focal segmental glomerulosclerosis confirmed by renal biopsy;
3. Patients who have not received hormone and/or immunosup therapy before the renal biopsy;

Exclusion Criteria

1. Presence of factors causing secondary membranous nephropathy: such as autoimmune diseases (systemic lupus erythematosus),/infections (viral hepatitis), drugs or toxins, etc.;
2. Severe infection: clinical manifestations such as fever, cough and sputum, throat, abdominal pain, diarrhea, boils and other skin and soft tissue infections, with white blood cell count in blood routine exceeding the normal range (10×09/L);
3. Severe cardiovascular disease: including chronic heart failure of grade 3 or above and various arrhythmias;
4. Infect diseases: active phase of various types of hepatitis, AIDS, syphilis, etc.;
5. Evidence of tumor: already diagnosed with a certain tumor or manifestations, tumor markers, etc. indicating the possibility of a tumor;
6. Patients with incomplete data or missed diagnosis.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zunsong Wang

OTHER

Sponsor Role lead

Responsible Party

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Zunsong Wang

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shandong Second Medical University. No.7166 Baotong West Street, Weifang, Shandong, 261053, China.

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zunsong Wang, Dr

Role: CONTACT

15966608835

Mengyu Wu, Dr

Role: CONTACT

17860690737

Facility Contacts

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Zunsong Wang

Role: primary

+86-15966608835

References

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Lima C, Muhamadali H, Goodacre R. The Role of Raman Spectroscopy Within Quantitative Metabolomics. Annu Rev Anal Chem (Palo Alto Calif). 2021 Jul 27;14(1):323-345. doi: 10.1146/annurev-anchem-091420-092323.

Reference Type BACKGROUND
PMID: 33826853 (View on PubMed)

Other Identifiers

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SERS-2024

Identifier Type: -

Identifier Source: org_study_id

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