NeuroborreliosisNCT06579235
Explorative Proteomics in Pediatric Neuroborreliosis
An observational study of Neuroborreliosis and Facial Palsy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Neuroborreliosis, Facial Palsy, Pediatric Infectious Disease
- What is being tested?
- Proteomics
- How many people
- 106 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Oct 2019to 10 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Presenting at a pediatric ward with facial nerve palsy and/or suspicion of lyme neuroborreliosis
- Parental informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Department of Children and Adolescents
Copenhagen, 2100
About this study
Official title: Explorative Proteomics to Ease the Diagnosis of 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.
Read the 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
- Being tested
- Proteomics
- Keywords
- Neuroborreliosis, Pediatric Infectious Disease, Proteomics
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteomicsDiagnostic test
All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.
| Study group | Role | What they receive |
|---|---|---|
| Children with neuroborreliosis | Not described Receives: Diagnostic Test: Proteomics | |
| Children without neuroborreliosis | Not described Receives: Diagnostic Test: Proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein concentrations
A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.
Measured: An average of 2 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start17 Oct 2019
- Primary completion10 Oct 2023
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroborreliosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen
- Responsible party
- Principal investigator, Joakim Bloch, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579235
- Sponsor's protocol ID
- 9365
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis
- ClinicalTrials.gov ID
- NCT06579235
- Acronym / sponsor ID
- 9365
- Conditions
- Neuroborreliosis, Facial Palsy, Pediatric Infectious Disease
- Keywords
- Neuroborreliosis, Pediatric Infectious Disease, Proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with neuroborreliosis | – | Diagnostic Test: Proteomics |
| Children without neuroborreliosis | – | Diagnostic Test: Proteomics |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Presenting at a pediatric ward with facial nerve palsy and/or suspicion of lyme neuroborreliosis
- Parental informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteomicsAll samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses. | Diagnostic test | Children with neuroborreliosis, Children without neuroborreliosis |
Primary outcome
Protein concentrations
Time frame: An average of 2 years from enrollment
A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroborreliosis and Facial Palsy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein concentrations (time frame: An average of 2 years from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.