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

Nephrotic Syndrome Clinical Trial

Official title:

Development and Validation of Hybrid Brillouin-Raman Spectroscopy for Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins as Biomarkers of Kidney Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04311684
• Other study ID #: 091019CRP2105
• Status: Active, not recruiting
• Start date: April 6, 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Nazarbayev University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome

Intervention

Device:
• hybrid Brillouin-Raman spectroscopy
Combination of Brillouin and surface-enhanced Raman (SERS) spectroscopy for assessment of both visco-elastic (i.e. mechanical) and chemical characterization of urinary proteins at the same time from the same excitation laser source

Locations

Country	Name	City	State
Kazakhstan	Nazarbayev University School of Medicine	Astana

Sponsors (3)

Lead Sponsor	Collaborator
Nazarbayev University	Astana Medical University, National Scientific Medical Center, Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (5)

Aitekenov S, Gaipov A, Bukasov R. Review: Detection and quantification of proteins in human urine. Talanta. 2021 Feb 1;223(Pt 1):121718. doi: 10.1016/j.talanta.2020.121718. Epub 2020 Oct 14. Review. — View Citation

Aitekenov S, Sultangaziyev A, Abdirova P, Yussupova L, Gaipov A, Utegulov Z, Bukasov R. Raman, Infrared and Brillouin Spectroscopies of Biofluids for Medical Diagnostics and for Detection of Biomarkers. Crit Rev Anal Chem. 2022 Feb 14:1-30. [Epub ahead of — View Citation

Gaipov A, Makhammajanov Z, Dauyey Z, Markhametova Z, Mussina K, Nogaibayeva A, Kozina L, Auganova D, Tarlykov P, Bukasov R, Utegulov Z, Turebekov D, Soler MJ, Ortiz A, Kanbay M. Urinary Protein Profiling for Potential Biomarkers of Chronic Kidney Disease:

Gaipov A, Utegulov Z, Bukasov R, Turebekov D, Tarlykov P, Markhametova Z, Nurekeyev Z, Kunushpayeva Z, Sultangaziyev A. Development and validation of hybrid Brillouin-Raman spectroscopy for non-contact assessment of mechano-chemical properties of urine pr — View Citation

Ikramova SB, Utegulov ZN, Dikhanbayev KK, Gaipov AE, Nemkayeva RR, Yakunin VG, Savinov VP, Timoshenko VY. Surface-Enhanced Raman Scattering from Dye Molecules in Silicon Nanowire Structures Decorated by Gold Nanoparticles. Int J Mol Sci. 2022 Feb 26;23(5) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome	Urine sample measurements by Brillouin and surface enhanced Raman (SERS) spectroscopy	four weeks
Secondary	Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome	Correlation and cross-validation of urinary protein Brillouin and SERS spectroscopy measurements by Liquid Chromatography-Mass Spectrometry (with proteomic measurements).	four weeks

External Links

•   Project Details