Clinical trial NCT04311684: Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins by Hybrid Brillouin-Raman Spectroscopy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nephrotic Syndrome
Keywords: urinary proteins
Brillouin spectroscopy
surface enhanced Raman spectroscopy
proteomics
non-invasive assessment
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: National Scientific Medical Center, Kazakhstan
name: Astana Medical University
First posted: 2020-03-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The proposed study will include 20 healthy subjects and age/gender matched 80 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. Exclusion criteria will be 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome
timeFrame: four weeks
Secondary outcomes:
measure: Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome
timeFrame: four weeks
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Nazarbayev University School of Medicine
Study officials:
affiliation: Nazarbayev University School of Medicine
name: Abduzhappar Gaipov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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):2590. doi: 10.3390/ijms23052590.
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. 2023;53(7):1561-1590. doi: 10.1080/10408347.2022.2036941. Epub 2022 Feb 14.
citation: 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.
citation: 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 proteins as biomarkers of kidney diseases. BMC Nephrol. 2020 Jun 15;21(1):229. doi: 10.1186/s12882-020-01890-x.
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: A Pilot Study. Diagnostics (Basel). 2022 Oct 25;12(11):2583. doi: 10.3390/diagnostics12112583.