Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:51 AM
Study NCT ID:
NCT07488702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intradurale Spinal Tumors: Management and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013120', 'term': 'Spinal Cord Neoplasms'}, {'id': 'D013125', 'term': 'Spinal Neoplasms'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological Functional Outcome Assessed', 'timeFrame': 'From preoperative assessment to last available follow-up (up to 24 months post-surgery)', 'description': 'Assessment of neurological functional status in patients undergoing surgical resection of intradural spinal tumors using the McCormick functional grading scale (Grade I: neurologically normal or mild deficit; Grade II: mild functional deficit, independent; Grade III: moderate deficit, limited independence; Grade IV: severe deficit, dependent; Grade V: paraplegia or quadriplegia). Preoperative and postoperative scores will be compared to evaluate changes in neurological function.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Complications', 'timeFrame': 'From surgery to 30 days postoperatively', 'description': 'Evaluation of postoperative complications, including hemorrhage, infections, dural fistula, and new neurological deficits, occurring after surgical treatment of intradural spinal tumors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intradural spinal tumors', 'Spinal cord neoplasms', 'Spinal tumor surgery', 'Neurosurgery', 'McCormick scale', 'Neurological outcome', 'Spinal cord compression', 'Retrospective study'], 'conditions': ['Spinal Cord Neoplasms', 'Spinal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Intradurale spinal tumors are rare neoplastic lesions that involve the spinal cord and surrounding structures and may cause neurological symptoms such as pain, motor deficits, sensory disturbances, and sphincter dysfunction. Surgical resection is often the primary treatment when feasible and may improve neurological outcomes and relieve spinal cord compression.\n\nThis retrospective observational study aims to analyze the epidemiological and clinical characteristics of patients who underwent surgical treatment for intradural spinal tumors at the Neurosurgery Unit of Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria between 2022 and 2024.\n\nClinical, radiological, and pathological data will be collected from electronic medical records, operative reports, and diagnostic imaging. The study will evaluate preoperative and postoperative neurological status using the McCormick functional scale, as well as postoperative complications and tumor recurrence.\n\nThe results of this study may contribute to improving the understanding of the clinical management of intradural spinal tumors and identifying factors associated with surgical outcomes and patient prognosis.', 'detailedDescription': 'Intradural spinal tumors are uncommon neoplastic lesions involving the spinal cord and its surrounding structures. These tumors may be classified as intradural extramedullary or intramedullary depending on their origin and anatomical location. Although relatively rare, they represent an important clinical condition due to their potential to cause progressive neurological impairment, including pain, motor weakness, sensory deficits, and sphincter dysfunction.\n\nMagnetic resonance imaging (MRI) represents the diagnostic gold standard for identifying and characterizing intradural spinal tumors. Surgical resection is generally considered the primary therapeutic option when feasible, with the aim of removing the lesion, decompressing the spinal cord, improving neurological symptoms, and obtaining a histological diagnosis. Advances in surgical techniques and intraoperative neurophysiological monitoring have contributed to improved surgical outcomes and postoperative recovery.\n\nThis study is a retrospective, single-center observational study conducted at the Neurosurgery Unit of the Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Italy. The study includes patients who underwent surgical treatment for intradural spinal tumors between 2022 and 2024.\n\nClinical data will be retrospectively collected from electronic medical records, surgical reports, imaging studies, and histopathological reports. The collected variables include demographic data, tumor characteristics (location and histology), clinical presentation, and postoperative outcomes.\n\nThe neurological functional status of patients will be evaluated using the McCormick functional scale, comparing preoperative and postoperative neurological conditions. Additional analyses will focus on postoperative complications and tumor recurrence.\n\nThe aim of this study is to provide a comprehensive description of the clinical and epidemiological characteristics of patients with intradural spinal tumors treated surgically at our institution and to contribute to a better understanding of the management and outcomes of this condition in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent surgical treatment for intradural spinal tumors at the Neurosurgery Unit of Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria between 2022 and 2024. Clinical, radiological, histological, and postoperative outcome data were retrospectively collected from medical records.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients hospitalized at Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo di Alessandria (Neurosurgery Unit).\n\nPatients who underwent surgical resection of an intradural spinal tumor.\n\nDiagnosis consistent with intradural spinal tumors according to ICD-9 codes.\n\nAvailability of clinical, radiological, and surgical data in medical records.\n\nSigned informed consent.\n\nExclusion Criteria:\n\nIncomplete medical records or missing clinical data required for the study.\n\nTumors with uncertain extradural extension identified during surgery.\n\nTumors arising from peripheral nerves.'}, 'identificationModule': {'nctId': 'NCT07488702', 'acronym': 'GTTIR', 'briefTitle': 'Intradurale Spinal Tumors: Management and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria'}, 'officialTitle': 'Intradurale Spinal Tumors: Management and Treatment - A Retrospective Observational Study', 'orgStudyIdInfo': {'id': 'ASO.Nch.25.02'}, 'secondaryIdInfos': [{'id': 'Novara Ethical Committee', 'type': 'OTHER', 'domain': '441.170'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients With Intradural Spinal Tumors', 'description': 'Patients who underwent surgical treatment for intradural spinal tumors at the Neurosurgery Unit of Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo di Alessandria between 2022 and 2024. Clinical, radiological, and histopathological data were collected retrospectively from medical records to evaluate patient characteristics, neurological outcomes, postoperative complications, and tumor recurrence.', 'interventionNames': ['Procedure: Surgical Resection of Intradural Spinal Tumors']}], 'interventions': [{'name': 'Surgical Resection of Intradural Spinal Tumors', 'type': 'PROCEDURE', 'description': 'This study consists of retrospective data collection and analysis of patients who underwent neurosurgical resection of intradural spinal tumors. No intervention is assigned as part of the study protocol.', 'armGroupLabels': ['Patients With Intradural Spinal Tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15121', 'city': 'Alessandria', 'state': 'Italia', 'country': 'Italy', 'facility': 'Neurosurgery Unit', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}