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Active, Not Recruiting

NCT Number: NCT06579235

Explorative Proteomics in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Department of Children and Adolescents

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proteomics

Diagnostic Test

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

Primary outcomes

  1. Protein concentrations

    Time frame: An average of 2 years from enrollment

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital
  • University of Copenhagen

Registry information

Official study title

Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Aug 30, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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