NCT06579235

Explorative Proteomics in Pediatric Neuroborreliosis

Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroborreliosis
• Facial Palsy
• Pediatric Infectious Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Proteomics	All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.

Timeline

• Start date: 2019-10-17
• Primary completion: 2023-10-10
• Completion: 2024-12-10
• First posted: 2024-08-30
• Last updated: 2024-09-03

Locations

1 site across 1 country: Denmark