Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-05 @ 2:17 AM
Study NCT ID:
NCT06579235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-03
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Explorative Proteomics in Pediatric Neuroborreliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005158', 'term': 'Facial Paralysis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood collected in EDTA-tubes.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein concentrations', 'timeFrame': 'An average of 2 years from enrollment', 'description': 'A matrix of concentrations of various proteins potentially relevant in diagnosing lyme neuroborreliosis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroborreliosis', 'Pediatric Infectious Disease', 'Proteomics'], 'conditions': ['Neuroborreliosis', 'Facial Palsy', 'Pediatric Infectious Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Objective:\n\nThe 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.\n\nMethods:\n\nParticipant Recruitment:\n\nThe investigators will enroll pediatric patients (aged 1 month to 17 years) presenting with suspected LNB.\n\nInformed consent will be obtained from parents or legal guardians.\n\nSample Collection:\n\nPeripheral blood samples will be collected from each participant in EDTA tubes. Samples will be processed to carry out proteomic analyses.\n\nProteomic Analysis:\n\nMass spectrometry will be employed to compare protein profiles between LNB-positive and LNB-negative patients.\n\nData Analysis and Presentations:\n\nProtein profiles will be analysed by trained bioinformaticians and mainly presented in volcano plots and heat maps.\n\nOutcome Measures:\n\nUnique proteomic profiles of children with LNB.\n\nExpected Impact:\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting at a pediatric ward with facial nerve palsy and/or suspicion of lyme neuroborreliosis\n* Parental informed consent\n\nExclusion Criteria:\n\n* Parents or legal guardians unable to understand given information or comply with study criteria\n* Patient unable to cooperate to study procedures (blood sample)\n* Unclear etiology after lumbar puncture'}, 'identificationModule': {'nctId': 'NCT06579235', 'briefTitle': 'Explorative Proteomics in Pediatric Neuroborreliosis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis', 'orgStudyIdInfo': {'id': '9365'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with neuroborreliosis', 'interventionNames': ['Diagnostic Test: Proteomics']}, {'label': 'Children without neuroborreliosis', 'interventionNames': ['Diagnostic Test: Proteomics']}], 'interventions': [{'name': 'Proteomics', 'type': 'DIAGNOSTIC_TEST', 'description': 'All samples of cases (with LNB) and controls (without LNB) will undergo proteomic analyses.', 'armGroupLabels': ['Children with neuroborreliosis', 'Children without neuroborreliosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, Department of Children and Adolescents', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Proteomics, Department of Clinical Biochemistry, Bispebjerg Hospital', 'class': 'UNKNOWN'}, {'name': 'NNF Center for Protein Research, University of Copenhagen', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical Doctor', 'investigatorFullName': 'Joakim Bloch', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}