NCT06760845 Raman Spectroscopy Diagnosis of Kidney Diseases
| NCT ID | NCT06760845 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zunsong Wang |
| Condition | IgA Nephropathy (IgAN) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-02-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06760845 clinical trial?
This trial is open to participants of all sexes, studying IgA Nephropathy (IgAN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06760845 currently recruiting?
Yes, NCT06760845 is actively recruiting participants. Contact the research team at wzsong3@163.com for enrollment information.
Where is the NCT06760845 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06760845 clinical trial?
NCT06760845 is sponsored by Zunsong Wang. The trial plans to enroll 200 participants.