- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311684
Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins by Hybrid Brillouin-Raman Spectroscopy
November 11, 2022 updated by: Nazarbayev University
Development and Validation of Hybrid Brillouin-Raman Spectroscopy for Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins as Biomarkers of Kidney Diseases
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Astana, Kazakhstan, 010000
- Nazarbayev University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with proteinuria
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
|
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
|
Healthy volunteers
Healthy men/women between age group 18-65 years will be included for urine protein measurements
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome
Time Frame: four weeks
|
Urine sample measurements by Brillouin and surface enhanced Raman (SERS) spectroscopy
|
four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome
Time Frame: four weeks
|
Correlation and cross-validation of urinary protein Brillouin and SERS spectroscopy measurements by Liquid Chromatography-Mass Spectrometry (with proteomic measurements).
|
four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abduzhappar Gaipov, MD, PhD, Nazarbayev University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Online ahead of print.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 6, 2020
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
March 14, 2020
First Submitted That Met QC Criteria
March 14, 2020
First Posted (ACTUAL)
March 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 16, 2022
Last Update Submitted That Met QC Criteria
November 11, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 091019CRP2105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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