Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 7:04 AM
Study NCT ID:
NCT01786460
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2013-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Injury Biomarkers in the General Population
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood, serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the putative biomarkers for TBI markers in general population using an investigational assay', 'timeFrame': 'up to 21 days'}], 'secondaryOutcomes': [{'measure': 'Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI', 'timeFrame': '0, 14, 7, and 21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Injuries, Traumatic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers who meet eligibility criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age and no more than 80 years of age\n* Willing to undergo consent\n* PI believes volunteer is appropriate candidate for study\n\nExclusion Criteria:\n\n* Participating in another clinical study that may affect the results of either study\n* Non-English speaking\n* Venipuncture not feasible\n* Blood donation within 1 week of screening\n* PI determines volunteer is not medically suitable for study participation'}, 'identificationModule': {'nctId': 'NCT01786460', 'briefTitle': 'Brain Injury Biomarkers in the General Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Banyan Biomarkers, Inc'}, 'orgStudyIdInfo': {'id': 'ATO-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'interventionNames': ['Other: Blood draw at Days 0, 7, 14, and 21']}], 'interventions': [{'name': 'Blood draw at Days 0, 7, 14, and 21', 'type': 'OTHER', 'armGroupLabels': ['Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Office of Nagi S. Ibrahim', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands at University Florida Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dekalb Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30045', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Medical Center', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Center for Clinical Research', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}], 'overallOfficials': [{'name': 'Jackson Streeter, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Banyan Biomarkers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Banyan Biomarkers, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}