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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Typhoid Fever

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Spectroscopic assessment of serum samples from healthy and typhoid fever patients to identify characteristics for diagnosis and staging.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy

The serum samples of healthy patients will be measured.

Group Type EXPERIMENTAL

Surface-enhanced Raman Spectroscopy

Intervention Type DIAGNOSTIC_TEST

The Raman spectra of patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

Early-stage typhoid fever

The serum samples of early-stage typhoid fever patients will be measured.

Group Type EXPERIMENTAL

Surface-enhanced Raman Spectroscopy

Intervention Type DIAGNOSTIC_TEST

The Raman spectra of patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

Consolidated-stage typhoid fever

The serum samples of consolidated-stage typhoid fever patients will be measured.

Group Type EXPERIMENTAL

Surface-enhanced Raman Spectroscopy

Intervention Type DIAGNOSTIC_TEST

The Raman spectra of patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

Interventions

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Surface-enhanced Raman Spectroscopy

The Raman spectra of 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 Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)