Raman Spectroscopy Diagnosis of Kidney Diseases

January 6, 2025 updated by: Zunsong Wang

Research on Raman Spectroscopy Detection Technology in Kidney Disease Diagnosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong Second Medical University. No.7166 Baotong West Street, Weifang, Shandong, 261053, China.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  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;

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time of enrollment to the completion of blood and urine collection within 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zunsong Wang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SERS-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Hematological and urinary biochemical indicators and Raman spectroscopic imaging

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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