Explorative Proteomics in Pediatric Neuroborreliosis

Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Facial Palsy; Pediatric Infectious Disease; Neuroborreliosis
• Intervention / Treatment: Diagnostic test: Proteomics

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Department of Children and Adolescents

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All children aged 1 month to 17 years presenting at pediatric wards in the capital region of Denmark with facial nerve palsy and/or suspicion of lyme neuroborreliosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with neuroborreliosis	Diagnostic test: Proteomics; All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.
Children without neuroborreliosis	Diagnostic test: Proteomics; All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein concentrations	A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.	An average of 2 years from enrollment

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Clinical Proteomics, Department of Clinical Biochemistry, Bispebjerg Hospital; NNF Center for Protein Research, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): October 10, 2023
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Proteomics; Pediatric Infectious Disease; Neuroborreliosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Facial Nerve Diseases; Infections; Communicable Diseases; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: 9365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No