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NCT Number: NCT06760845

Raman Spectroscopy Diagnosis of Kidney Diseases

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presence of factors causing secondary membranous nephropathy: such as autoimmune diseases (systemic lupus erythematosus),/infections (viral hepatitis), drugs or toxins, etc.;
  • 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);
  • Severe cardiovascular disease: including chronic heart failure of grade 3 or above and various arrhythmias;
  • Infect diseases: active phase of various types of hepatitis, AIDS, syphilis, etc.;
  • Evidence of tumor: already diagnosed with a certain tumor or manifestations, tumor markers, etc. indicating the possibility of a tumor;
  • Patients with incomplete data or missed diagnosis.

Treatment and study plan

Imaging Time

Diagnostic Test

Raman spectroscopy images of blood and urine

Primary outcomes

  1. Raman spectroscopy images of blood and urine

    Time frame: From the time of enrollment to the completion of blood and urine collection within 2 days

    The samples were scanned using a Raman spectrometer to obtain Raman spectral data. The scattering peaks in the Raman spectra were analyzed by fitting Gaussian curves using Origin software. The chemical bonds were identified and the presence of compounds was confirmed by referring to the literature based on the peak positions.

    The peak and area of the chemical substances in the Raman spectra were calculated and used to plot calibration curves, thereby establishing the quantitative analysis equation. This equation was used to calculate the concentrations of each analyte in the serum and urine.

    The average concentration data for each pathological patient group were used as the basis for multivariate analysis, such as principal component analysis (PCA) and Mahalanobis distance discriminant model, to classify and predict the types of diseases.

Study contacts

Contact information is provided by the study sponsor or research team.

Mengyu Wu, Dr

CONTACT

[email protected]

17860690737

Zunsong Wang, Dr

CONTACT

[email protected]

15966608835

Sponsors and collaborators

Lead sponsor

Zunsong Wang

Other

Registry information

Official study title

Research on Raman Spectroscopy Detection Technology in Kidney Disease Diagnosis

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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