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

University Hospital, Aachen

Status: Active, not recruiting

Conditions: Diabetes

Treatments: Diagnostic Test: SERS

Study type: Interventional

Funder types: Other

Identifiers

NCT06862778

Diabetes SERS 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Healthy

Experimental group

Description:

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.

Treatment:

Diagnostic Test: SERS

Diabetes

Experimental group

Description:

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.

Treatment:

Diagnostic Test: SERS