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

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Nazarbayev University School of Medicine

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
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
Healthy volunteers
Healthy men/women between age group 18-65 years will be included for urine protein measurements
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

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

Nazarbayev University

Collaborators

Astana Medical University
National Scientific Medical Center, Kazakhstan

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

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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