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临床试验/NCT06862778
NCT06862778已完成不适用

Clinical Diagnosis of Diabetes Using Surface-enhanced Raman Spectroscopy Liquid Biopsy and Machine Learning

University Hospital, Aachen1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
SERS measurements to differentiate between healthy and diabetic patients

研究概览

简要总结

This project aims 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 investigate whether SERS (combined with multivariate data analysis or machine learning algorithms) allows the diagnosis of patients with diabetes.

详细描述

This study on the clinical application of surface-enhanced Raman spectroscopy (SERS) comprises two parts. First, a SERS measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patient's 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 removing 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 diabetes patients. Two different approaches will be followed. First, multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and diabetes patients), allowing patient diagnosis. Second, different machine learning algorithms and data augmentation strategies will be explored for better patient diagnosis.

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
是

入选标准

  • •Patient at Nishtar Medical University
  • •Patient age from 18 to 70 years
  • •Confirmed disease (for diabetic group)

排除标准

  • •Patients with severe concurrent diseases

研究组 & 干预措施

Healthy

Experimental

The Raman spectra of healthy patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

干预措施: SERS (Diagnostic Test)

Diabetes

Experimental

The Raman spectra of diabetic patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

干预措施: SERS (Diagnostic Test)

结局指标

主要结局

SERS measurements to differentiate between healthy and diabetic patients

时间窗: Through study competition, up to 1 year

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

次要结局

未报告次要终点

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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