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Clinical Trials/NCT06862778
NCT06862778CompletedNot Applicable

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

University Hospital, Aachen1 site in 1 country52 target enrollmentStarted: February 2, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
SERS measurements to differentiate between healthy and diabetic patients

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Healthy

Experimental

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.

Intervention: SERS (Diagnostic Test)

Diabetes

Experimental

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.

Intervention: SERS (Diagnostic Test)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Aachen
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roger Molto Pallares

Group Leader

University Hospital, Aachen

Study Sites (1)

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