Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT05608460
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15700}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive Values of CT, XR, and MRI', 'timeFrame': '5 years', 'description': 'The sensitivity, specificity, negative and positive predictive values of CT, XR, and MRI for clinically significant injury will be calculated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Spine Fracture']}, 'descriptionModule': {'briefSummary': "A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any participant less than 18 years old after blunt trauma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any participant less than 18 years old after blunt trauma\n* Seen by trauma service\n* With cervical spine imaging (XR, CT, or MRI)\n\nExclusion Criteria:\n\n* CT scan from outside facility is poor quality and not repeated (\\<63-channel, cuts \\>3mm, no reformats, motion artifact)\n* No radiology over reads by participating institution'}, 'identificationModule': {'nctId': 'NCT05608460', 'briefTitle': 'Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study', 'orgStudyIdInfo': {'id': 'C-Spine'}}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Nguyen', 'role': 'CONTACT'}, {'name': 'Ben Padilla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Houshmand', 'role': 'CONTACT'}, {'name': 'Lorraine Kelley-Quon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Romeo Ignacio, MD', 'role': 'CONTACT'}, {'name': 'Romeo Ignacio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Jensen, MD', 'role': 'CONTACT'}, {'name': 'Aaron Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachelle Balili', 'role': 'CONTACT'}, {'name': 'Stephanie Chao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Lucile Packard Children's Hospital", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Connor Prendergast', 'role': 'CONTACT'}, {'name': 'Shannon Acker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jose Diaz-Miron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Mason', 'role': 'CONTACT'}, {'name': 'Katrine Lofberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Valencia', 'role': 'CONTACT'}, {'name': 'Samir Pandya, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kezlyn Larsen, BS', 'role': 'CONTACT'}, {'name': 'Katie Russell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Kezlyn Larsen, BS', 'role': 'CONTACT', 'email': 'kezlyn.larsen@hsc.utah.edu', 'phone': '801-662-2989'}], 'overallOfficials': [{'name': 'Katie Russell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katie Russell, MD', 'investigatorAffiliation': 'University of Utah'}}}}