An observational study in Neuroborreliosis, Facial Palsy and Pediatric Infectious Disease, sponsored by Rigshospitalet, Denmark. Active, not recruiting at 1 site in Denmark. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.
This study's enrollment of 106 is above the median of 80 across 21 observational studies indexed under Facial Paralysis.
Browse Facial Paralysis studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Proteomics
Diagnostic Test: Proteomics
All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.
Protein concentrations
A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.
Time frame: An average of 2 years from enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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