Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Explorative Proteomics in Pediatric Neuroborreliosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis
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:
This study aims to use proteomic analysis to diagnose Lyme Neuroborreliosis LNB in children Pediatric patients with suspected LNB will be enrolled and their blood samples will be collected for proteomic analyses Mass spectrometry will be used to compare protein profiles of LNB-positive and LNB-negative patients The data will be analyzed by bioinformaticians The expected impact is to establish a non-invasive reliable method for early LNB diagnosis to improve patient outcomes
Detailed Description:
Objective
The primary objective of this study is to investigate the utility of proteomic analysis in diagnosing lyme neuroborreliosis LNB in children By identifying specific protein markers associated with LNB proteomics the investigators aim to enhance early detection and improve patient outcomes
Methods
Participant Recruitment
The investigators will enroll pediatric patients aged 1 month to 17 years presenting with suspected LNB
Informed consent will be obtained from parents or legal guardians
Sample Collection
Peripheral blood samples will be collected from each participant in EDTA tubes Samples will be processed to carry out proteomic analyses
Proteomic Analysis
Mass spectrometry will be employed to compare protein profiles between LNB-positive and LNB-negative patients
Data Analysis and Presentations
Protein profiles will be analysed by trained bioinformaticians and mainly presented in volcano plots and heat maps
Outcome Measures
Unique proteomic profiles of children with LNB
Expected Impact
This study aims to establish a non-invasive and reliable method for diagnosing LNB in children Early identification will facilitate timely treatment and prevent complications associated with LNB
The primary objective of this study is to investigate the utility of proteomic analysis in diagnosing lyme neuroborreliosis LNB in children By identifying specific protein markers associated with LNB proteomics the investigators aim to enhance early detection and improve patient outcomes
Methods
Participant Recruitment
The investigators will enroll pediatric patients aged 1 month to 17 years presenting with suspected LNB
Informed consent will be obtained from parents or legal guardians
Sample Collection
Peripheral blood samples will be collected from each participant in EDTA tubes Samples will be processed to carry out proteomic analyses
Proteomic Analysis
Mass spectrometry will be employed to compare protein profiles between LNB-positive and LNB-negative patients
Data Analysis and Presentations
Protein profiles will be analysed by trained bioinformaticians and mainly presented in volcano plots and heat maps
Outcome Measures
Unique proteomic profiles of children with LNB
Expected Impact
This study aims to establish a non-invasive and reliable method for diagnosing LNB in children Early identification will facilitate timely treatment and prevent complications associated with LNB
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