ClinicalTrials.gg
CompletedNCT06546982Updated Mar 5, 2025

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

An interventional study of Surface-enhanced Raman Spectroscopy in Typhoid Fever, sponsored by University Hospital, Aachen. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by University Hospital, Aachen · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Typhoid Fever

Browse trials for

03

In context

Typhoid Fever

76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.

This study's enrollment of 30 is below the median of 147 across 65 interventional studies indexed under Typhoid Fever.

Browse Typhoid Fever studies →

Lead sponsor

University Hospital, Aachen is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with severe concurrent diseases were excluded from the study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Healthy

    The serum samples of healthy patients will be measured.

    Diagnostic Test: Surface-enhanced Raman Spectroscopy

  • Experimental
    Early-stage typhoid fever

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

    Diagnostic Test: Surface-enhanced Raman Spectroscopy

  • Experimental
    Consolidated-stage typhoid fever

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

    Diagnostic Test: Surface-enhanced Raman Spectroscopy

Interventions

  • Diagnostic testSurface-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.

06

What researchers measure

Primary outcomes

  1. SERS measurements to differentiate between healthy and typhoid fever patients

    SERS assessment of healthy and typhoid fever patient samples to identify unique spectroscopical characteristics to discriminate between healthy and typhoid fever patients

    Time frame: Through study competition, up to 1 year

Secondary outcomes

  1. SERS measurements to stage typhoid fever patients

    SERS assessment of early-stage and consolidated-stage typhoid fever patient samples to identify unique spectroscopical characteristics to stage the infection.

    Time frame: Through study competition, up to 1 year

07

Study locations

1 site
  • Roger Molto Pallares
    Aachen, Northwest 52074, Germany
08

References and documents

Publications

  • 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. PubMed 39938329 ↗

Individual participant data

Plan to share: No — The study results will be published in at least one scientific article.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in Aug 2024, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2024
First posted
Aug 9, 2024
StartActual
Jul 15, 2023
Primary completionActual
Aug 15, 2024
CompletionActual
Dec 15, 2024
Last update
Mar 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06546982
Lead sponsor
University Hospital, Aachen
Collaborators
University of Agriculture Faisalabad, Nishtar Medical University
Responsible party
Roger Molto Pallares (Group Leader, University Hospital, Aachen) — Principal investigator
First posted
Aug 9, 2024
Start date
Jul 15, 2023
Primary completion
Aug 15, 2024
Completion
Dec 15, 2024
Last update
Mar 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion