Viewing Study NCT06546982



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06546982
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: None
First Post: 2024-08-02

Brief Title: Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy
Sponsor: None
Organization: None

Study Overview

Official Title: Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None