IgA Nephropathy (IgAN)NCT06760845
Raman Spectroscopy Diagnosis of Kidney Diseases
An observational study of IgA Nephropathy (IgAN) and Membranous Nephropathy, run by Zunsong Wang at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy (IgAN), Membranous Nephropathy, Diabetic Nephropathy
- What is being tested?
- Imaging Time
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to Jul 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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;
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Second Medical University. No.7166 Baotong West Street, Weifang, Shandong, 261053, China.
Jinan, Shandong, 250000
Zunsong Wang, +86-15966608835, wzsong3@163.com
About this study
Official title: 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.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, Diabetic Nephropathy, Focal Segmental Glomerulosclerosis (FSGS)
- Being tested
- Imaging Time
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulonephritis, Membranous, Diabetic Nephropathies, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging TimeDiagnostic test
Raman spectroscopy images of blood and urine
What is being measured
The primary outcome is the main question the study is designed to answer.
Raman spectroscopy images of blood and urine
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.
Measured: From the time of enrollment to the completion of blood and urine collection within 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Feb 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zunsong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zunsong Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760845
- Sponsor's protocol ID
- SERS-2024
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Hematological and urinary biochemical indicators and Raman spectroscopic imaging
Publications
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.
PubMed 33826853