Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins by Hybrid Brillouin-Raman Spectroscopy

Active, not recruiting

• Conditions: Nephrotic Syndrome
• Interventions: Device: hybrid Brillouin-Raman spectroscopy

• Registration Number: NCT04311684
• Lead Sponsor: Nazarbayev University

Brief Summary

The proteinuria is widely recognized as a marker of kidney disease severity, as well as the predictor of renal function decline, cardiovascular outcomes, and all-cause mortality. However, the severity of kidney disease progression and these outcomes differs among patients with various amount of proteinuria. The potential mechanism underlining this disparity may be relevant to the quality and quantity of filtered proteins, especially their mechano-chemical properties such as physical viscosity and stiffness, amino-acid sequence, and molecular weight (low, middle and high molecular weight proteins). The goal of the current project is to develop and validate combined Brillouin \& Surface-Enhanced Raman Scattering (SERS) Spectroscopy technique for simultaneous non-contact assessment of visco-elastic and chemical properties of urine proteins as biomarkers of kidney disease. Systematic studies of these properties of proteins in urine samples to be taken from diseased and healthy subjects will be cross-validated by Liquid Chromatography-Mass Spectrometry (LCMS). The project ultimately aims for the development of an optical spectroscopic sensor for rapid, non-contact monitoring of urine samples from patients in clinical settings.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-14
• Study First Posted: 2020-03-17
• Study Start: 2020-04-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-11-16
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Both male and female patients with any ethnic group, aged between 18-65 years old
• Newly diagnosed patients with glomerulonephritis and different range of proteinuria

Exclusion Criteria

• patients aged <18 and >65 years,
• eGFR<60 ml/min,
• pregnant females,
• patients with diabetes mellitus, cancer, infectious diseases, and other life-treating comorbidities/conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	hybrid Brillouin-Raman spectroscopy	Healthy men/women between age group 18-65 years will be included for urine protein measurements
Patients with proteinuria	hybrid Brillouin-Raman spectroscopy	Patients with newly diagnosed glomerulonephritis with different range of proteinuria at the age between 18-65 years and estimated glomerular filtration rate (GFR) ≥60 ml/min will be included for urine protein measurements

Primary Outcome Measures

Name	Time	Method
Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome	four weeks	Urine sample measurements by Brillouin and surface enhanced Raman (SERS) spectroscopy

Secondary Outcome Measures

Name	Time	Method
Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome	four weeks	Correlation and cross-validation of urinary protein Brillouin and SERS spectroscopy measurements by Liquid Chromatography-Mass Spectrometry (with proteomic measurements).

Trial Locations

Locations (1)

Nazarbayev University School of Medicine; 🇰🇿 Astana, Kazakhstan