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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06862778
Enrollment
52
Registered
2025-03-06
Start date
2024-02-02
Completion date
2025-07-31
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Sensing, SERS, Gold nanoparticles, Diagnositcs, Surface-enhanced Raman Spectroscopy

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.

Interventions

DIAGNOSTIC_TESTSERS

Spectroscopic assessment of serum samples from healthy and diabetic patients to identify characteristics for diagnosis.

Sponsors

University Hospital, Aachen
Lead SponsorOTHER
University of Agriculture Faisalabad
CollaboratorUNKNOWN
Nishtar Medical University
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
SERS measurements to differentiate between healthy and diabetic patientsThrough study competition, up to 1 yearSERS assessment of healthy and diabetic patient samples to identify unique spectroscopical characteristics to discriminate between healthy and diabetic patients

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026