Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy

Not Applicable

Completed

• Conditions: Typhoid Fever
• Interventions: Diagnostic Test: Surface-enhanced Raman Spectroscopy

• Registration Number: NCT06546982
• Lead Sponsor: University Hospital, Aachen

Brief Summary

The goal of this project is 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 subsequently investigate whether SERS allows to diagnose patients infected with typhoid fever as well as to stage the disease.

Detailed Description

This study on the clinical application of surface-enhanced Raman spectroscopy (SERS) is composed of two parts. First, a SERS measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patients 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 the removal of 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 typhoid fever patients. The samples from infected patients will be confirmed with the Widal test. Multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and infected patients), allowing patient diagnosis, as well as the severity of the infection.

Study Timeline

• Study Start: 2023-07-15
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Primary Completion: 2024-08-15
• Study Completion: 2024-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient at Nishtar Medical University
• The age range of the patients was from 18 to 70 years
• Confirmed disease with the Widal test (for typhoid fever groups)

Exclusion Criteria

• Patients with severe concurrent diseases were excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Consolidated-stage typhoid fever	Surface-enhanced Raman Spectroscopy	The serum samples of consolidated-stage typhoid fever patients will be measured.
Healthy	Surface-enhanced Raman Spectroscopy	The serum samples of healthy patients will be measured.
Early-stage typhoid fever	Surface-enhanced Raman Spectroscopy	The serum samples of early-stage typhoid fever patients will be measured.

Primary Outcome Measures

Name	Time	Method
SERS measurements to differentiate between healthy and typhoid fever patients	Through study competition, up to 1 year	SERS assessment of healthy and typhoid fever patient samples to identify unique spectroscopical characteristics to discriminate between healthy and typhoid fever patients

Secondary Outcome Measures

Name	Time	Method
SERS measurements to stage typhoid fever patients	Through study competition, up to 1 year	SERS assessment of early-stage and consolidated-stage typhoid fever patient samples to identify unique spectroscopical characteristics to stage the infection.

Trial Locations

Locations (1)

Roger Molto Pallares; 🇩🇪 Aachen, Northwest, Germany