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

U

University Hospital, Aachen

Status

Active, not recruiting

Conditions

Typhoid Fever

Treatments

Diagnostic Test: Surface-enhanced Raman Spectroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT06546982
Typhoid Fever SERS 01

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

30 participants in 3 patient groups

Healthy
Experimental group
Description:
The serum samples of healthy patients will be measured.
Treatment:
Diagnostic Test: Surface-enhanced Raman Spectroscopy
Early-stage typhoid fever
Experimental group
Description:
The serum samples of early-stage typhoid fever patients will be measured.
Treatment:
Diagnostic Test: Surface-enhanced Raman Spectroscopy
Consolidated-stage typhoid fever
Experimental group
Description:
The serum samples of consolidated-stage typhoid fever patients will be measured.
Treatment:
Diagnostic Test: Surface-enhanced Raman Spectroscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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