Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-28 @ 10:38 AM
Study NCT ID:
NCT05684835
Status:
UNKNOWN
Last Update Posted:
2023-01-17
First Post:
2023-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve origin', 'timeFrame': 'within 1 month', 'description': 'intraoperative identification of the nerve origin of the tumor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Nerve Sheath Tumors', 'Schwannoma of Neck']}, 'referencesModule': {'references': [{'pmid': '37204443', 'type': 'DERIVED', 'citation': 'Wong CE, Huang CC, Chuang MT, Lee PH, Chen LY, Hsu HH, Huang CY, Wang LC, Lee JS. Quantification of vessel separation using the carotid-jugular angle to predict the nerve origin of neck peripheral nerve sheath tumours: a pooled analysis of cases from the literature and a single-center cohort. Int J Surg. 2023 Sep 1;109(9):2704-2713. doi: 10.1097/JS9.0000000000000491.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors. This study is a retrospective cohort aimed to predict the nerve origin of neck peripheral nerve sheath tumors. Accurate preoperative identification of the nerve origin can improve surgical outcomes and patient counseling', 'detailedDescription': 'Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors (PNSTs). Accurate preoperative identification of the nerve origin (NO) can improve surgical outcomes and patient counseling. This study aims to predict the NO of neck PNSTs with radiographic analysis. This study is a retrospective cohort analysis. Radiographic parameters will be reviewed and the sensitivity, specificity, accuracy of NO prediction will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an intraoperatively confirmed neck PNST and NO between January 2008 and December 2022 who underwent surgical excision of neck PNST with anterior approach, excluding patients with previous anterior neck surgery, malignant disease, prior neck radiation, and undetermined intraoperative NO.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical diagnosis of neck peripheral nerve sheath tumors.\n* Patients received surgery January 2008 and December 2022.\n* The nerve origin of peripheral nerve sheath tumor must be intraoperatively confirmed.\n\nExclusion Criteria:\n\n* Previous anterior neck surgery.\n* Malignant disease.\n* Prior neck radiation.\n* Undetermined intraoperative nerve origin.'}, 'identificationModule': {'nctId': 'NCT05684835', 'briefTitle': 'Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors: Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'A-ER-109-209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vagus nerve tumor group', 'description': 'patients with neck peripheral nerve sheath tumors originating from the vagus nerve', 'interventionNames': ['Procedure: Excision']}, {'label': 'Sympathetic nerve tumor group', 'description': 'patients with neck peripheral nerve sheath tumors originating from the sympathetic nerve', 'interventionNames': ['Procedure: Excision']}, {'label': 'Cervical spinal nerve tumor group', 'description': 'patients with neck peripheral nerve sheath tumors originating from the cervical spinal nerve', 'interventionNames': ['Procedure: Excision']}], 'interventions': [{'name': 'Excision', 'type': 'PROCEDURE', 'description': 'All patients underwent surgery under general anesthesia and intraoperative neuromonitoring according to the preoperatively predicted NO. Using an anterior cervical approach, the tumor was delineated after identifying the relationships among the great vessels, nerves, and tumors. The NO was confirmed intraoperatively. Sharp dissection was performed meticulously to enucleate the tumor from the NO to preserve most nerve fibers.', 'armGroupLabels': ['Cervical spinal nerve tumor group', 'Sympathetic nerve tumor group', 'Vagus nerve tumor group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chi-Chen Huang, MD', 'role': 'CONTACT', 'email': 'charles042085@hotmail.com', 'phone': '06-2353535', 'phoneExt': '258821'}], 'facility': 'National Cheng-Kung University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chi-Chen Huang, MD', 'role': 'CONTACT', 'email': 'charles042085@hotmail.com', 'phone': '06-2353535', 'phoneExt': '258821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor', 'investigatorFullName': 'Chi Chen Huang', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}