Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
106 participants
OBSERVATIONAL
2019-10-17
2024-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Direct Diagnosis of Disseminated Lyme Borreliosis.
NCT04719962
Lyme Borreliosis and Early Cutaneous Diagnostic
NCT02414789
Next Generation Sequencing Detection of Lyme Disease
NCT03505879
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
NCT00138801
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
NCT02741609
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Children with neuroborreliosis
Proteomics
All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.
Children without neuroborreliosis
Proteomics
All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Proteomics
All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Parental informed consent
Exclusion Criteria
* Patient unable to cooperate to study procedures (blood sample)
* Unclear etiology after lumbar puncture
1 Month
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinical Proteomics, Department of Clinical Biochemistry, Bispebjerg Hospital
UNKNOWN
NNF Center for Protein Research, University of Copenhagen
UNKNOWN
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joakim Bloch
Principal Investigator, Medical Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rigshospitalet, Department of Children and Adolescents
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9365
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.