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临床试验/NCT06546982
NCT06546982已完成不适用

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

University Hospital, Aachen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
SERS measurements to differentiate between healthy and typhoid fever patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Patients with severe concurrent diseases were excluded from the study

结局指标

主要结局

SERS measurements to differentiate between healthy and typhoid fever patients

时间窗: Through study competition, up to 1 year

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

次要结局

  • SERS measurements to stage typhoid fever patients(Through study competition, up to 1 year)

研究者

发起方
University Hospital, Aachen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roger Molto Pallares

Group Leader

University Hospital, Aachen

研究点 (1)

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