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Explorative Proteomics in Pediatric Neuroborreliosis

Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06579235
Enrollment
106
Registered
2024-08-30
Start date
2019-10-17
Completion date
2024-12-10
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Palsy, Neuroborreliosis, Pediatric Infectious Disease

Keywords

Neuroborreliosis, Pediatric Infectious Disease, Proteomics

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.

Interventions

DIAGNOSTIC_TESTProteomics

All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.

Sponsors

Clinical Proteomics, Department of Clinical Biochemistry, Bispebjerg Hospital
CollaboratorUNKNOWN
NNF Center for Protein Research, University of Copenhagen
CollaboratorUNKNOWN
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Protein concentrationsAn average of 2 years from enrollmentA matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026