Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT04288167
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2020-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The laboratories will analyze the samples blinded, without knowing whether the sample was from an injured patient or a healthy control.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker levels', 'timeFrame': '12 months', 'description': 'Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay'}, {'measure': 'Biomarker profiles', 'timeFrame': '12 months', 'description': 'Characterization of different glycan structures present in the sample by mass spectrometry analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Injuries, Traumatic']}, 'descriptionModule': {'briefSummary': 'The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.', 'detailedDescription': 'The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Minute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15)\n* No more that 6 hours elapsed from the incident of injury at the first sampling\n* The patient is conscious\n* Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures\n\nExclusion Criteria:\n\n* More than 6 hours elapsed from the injury, or unknown time of trauma\n* Multi-trauma patient\n* History of head injury, seizures or stroke within three preceding months\n* Chronic neurodegenerative, metabolic or autoimmune disease\n* Known existing neurological condition'}, 'identificationModule': {'nctId': 'NCT04288167', 'briefTitle': 'Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicortex Finland Oy'}, 'officialTitle': 'Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents', 'orgStudyIdInfo': {'id': 'T257/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with suspected brain injury', 'description': 'This arm will consist of up to 30 pediatric patients who entered the Emergency Room and who are suspected of having mild traumatic brain injury. Two sample sets will be collected within the first 10 hours from the injury.', 'interventionNames': ['Diagnostic Test: Sample collection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'This arm will consist of up to 30 healthy control subjects, the samples of whom will be compared to the samples of brain injury patients (Arm 1). One sample set will be collected from healthy children without any known brain injury.', 'interventionNames': ['Diagnostic Test: Sample collection']}], 'interventions': [{'name': 'Sample collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Samples of urine and saliva will be collected from participants using customary sample collection means.', 'armGroupLabels': ['Healthy controls', 'Patients with suspected brain injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28500', 'city': 'Pori', 'country': 'Finland', 'facility': 'Satakunta Central Hospital', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}], 'overallOfficials': [{'name': 'Sari Malmi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satasairaala'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data shall not be shared to outside of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicortex Finland Oy', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Satasairaala', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}