Explorative Proteomics in Pediatric Neuroborreliosis

Active, not recruiting

• Conditions: Neuroborreliosis; Facial Palsy; Pediatric Infectious Disease
• Interventions: Diagnostic Test: Proteomics

• Registration Number: NCT06579235
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2019-10-17
• Primary Completion: 2023-10-10
• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-29
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-09-03
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Presenting at a pediatric ward with facial nerve palsy and/or suspicion of lyme neuroborreliosis
• Parental informed consent

Exclusion Criteria

• Parents or legal guardians unable to understand given information or comply with study criteria
• Patient unable to cooperate to study procedures (blood sample)
• Unclear etiology after lumbar puncture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with neuroborreliosis	Proteomics	-
Children without neuroborreliosis	Proteomics	-

Primary Outcome Measures

Name	Time	Method
Protein concentrations	An average of 2 years from enrollment	A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.

Trial Locations

Locations (1)

Rigshospitalet, Department of Children and Adolescents; 🇩🇰 Copenhagen, Denmark