Explorative Proteomics in Pediatric Neuroborreliosis

NCT06579235 | Active Not Recruiting DMC

• 1 other identifier: 9365
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroborreliosis; Facial Palsy; Pediatric Infectious Disease

Keywords

Neuroborreliosis; Pediatric Infectious Disease; Proteomics

Outcome Measures

Primary Outcomes (1)

• Protein concentrations

  A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.

  An average of 2 years from enrollment

Study Arms (2)

Children with neuroborreliosis

Diagnostic Test: Proteomics

Children without neuroborreliosis

Diagnostic Test: Proteomics

Interventions

Proteomics DIAGNOSTIC_TEST

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

Children with neuroborreliosis; Children without neuroborreliosis

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Bispebjerg Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Rigshospitalet, Department of Children and Adolescents

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood collected in EDTA-tubes.

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: October 17, 2019
• Primary Completion: October 10, 2023
• Study Completion: December 10, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)