Clinical Diagnosis of Diabetes Using Surface-enhanced Raman Spectroscopy Liquid Biopsy and Machine Learning

April 27, 2026 updated by: Roger Molto Pallares, University Hospital, Aachen
This project aims to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study, a measurement protocol will be established to investigate whether SERS (combined with multivariate data analysis or machine learning algorithms) allows the diagnosis of patients with diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study on the clinical application of surface-enhanced Raman spectroscopy (SERS) comprises two parts. First, a SERS measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patient's samples, maximizing Raman spectroscopical signatures. Given the complex composition of human blood, which encompasses numerous biological constituents, the study focuses on serum, a component obtained through centrifugation after removing cells and clotting factors. Fifteen spectra will be recorded per sample. The raw spectra will be post-processed, including removal of the substrate signal, baseline correction, vector normalization, and smoothing steps.

The SERS measurement protocol established in the first section will subsequently be applied to samples of healthy and diabetes patients. Two different approaches will be followed. First, multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and diabetes patients), allowing patient diagnosis. Second, different machine learning algorithms and data augmentation strategies will be explored for better patient diagnosis.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

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

  • Germany
      • Aachen, Germany, 52074
        • RWTH Aachen University Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient at Nishtar Medical University
  • Patient age from 18 to 70 years
  • Confirmed disease (for diabetic group)

Exclusion Criteria:

  • Patients with severe concurrent diseases

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy
The Raman spectra of healthy patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.
Diagnostic test: SERS
Spectroscopic assessment of serum samples from healthy and diabetic patients to identify characteristics for diagnosis.
Other Names:
  • Surface-enhanced Raman Spectroscopy
Experimental: Diabetes
The Raman spectra of diabetic patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.
Diagnostic test: SERS
Spectroscopic assessment of serum samples from healthy and diabetic patients to identify characteristics for diagnosis.
Other Names:
  • Surface-enhanced Raman Spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SERS measurements to differentiate between healthy and diabetic patients
Time Frame: Through study competition, up to 1 year
SERS assessment of healthy and diabetic patient samples to identify unique spectroscopical characteristics to discriminate between healthy and diabetic patients
Through study competition, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Aachen

Collaborators

Nishtar Medical University
University of Agriculture Faisalabad

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)

February 2, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 1, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetes SERS 01

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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