Clinical trial NCT06546982: Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy
Official title: Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Typhoid Fever
Lead sponsor: University Hospital, Aachen
Sponsor class: OTHER
Collaborators: name: University of Agriculture Faisalabad
name: Nishtar Medical University
First posted: 2024-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Spectroscopic assessment of serum samples from healthy and typhoid fever patients to identify characteristics for diagnosis and staging.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: SERS measurements to differentiate between healthy and typhoid fever patients
timeFrame: Through study competition, up to 1 year
Secondary outcomes:
measure: SERS measurements to stage typhoid fever patients
timeFrame: Through study competition, up to 1 year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Roger Molto Pallares
state: Northwest
Study officials:
References:
citation: Ditta A, Zhang R, Nawaz H, Majeed MI, He S, Zhuang Z, Rutten S, Shahzadi A, Yaseen S, Kiessling F, Hu J, Lammers T, Pallares RM. An exploratory clinical study of the diagnosis and staging of typhoid fever using label-free surface-enhanced Raman spectroscopy liquid biopsy. Spectrochim Acta A Mol Biomol Spectrosc. 2025 May 15;333:125864. doi: 10.1016/j.saa.2025.125864. Epub 2025 Feb 4.