Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT05793034
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors for Survival in Aggressive Meningiomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival (RFS)', 'timeFrame': '5 years on average', 'description': 'Correlation from biomolecular data and RFS'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years on average', 'description': 'Correlation from biomolecular data and OS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningioma', 'Meningioma Atypical', 'Anaplastic Meningioma']}, 'descriptionModule': {'briefSummary': 'The investigators plan to collect clinical and molecular data, including ICH, PCR, NGS and methylome, from patients operated on for grade 2 or grade 3 meningioma. The purpose of the study is to identify reliable and easy-to-assess predictive factors for recurrence and survival after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient operated for atypical (grade 2) meningioma; or\n2. Patient operated for anaplastic (grade 3) meningioma;\n3. Timeframe for surgery, 1999-2019\n\nExclusion criteria\n\n1\\) Patient lost at follow-up'}, 'identificationModule': {'nctId': 'NCT05793034', 'acronym': '23Men', 'briefTitle': 'Predictive Factors for Survival in Aggressive Meningiomas', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Analysis of Predictive Factors for Overall and Progression-free Survival After Neurosurgery for Atypical or Anaplastic Meningioma', 'orgStudyIdInfo': {'id': '3459'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Biological biomarker assessment', 'description': 'FFPE tumor tissue will be processed with a number of molecular biology techniques', 'interventionNames': ['Diagnostic Test: Biological biomarker assessment']}], 'interventions': [{'name': 'Biological biomarker assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'IHC, PCR, NGS, methylome', 'armGroupLabels': ['Biological biomarker assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Olivi, MD', 'role': 'CONTACT', 'email': 'alessandro.olivi@policlinicogemelli.it', 'phone': '+39 06 3015 4120'}, {'name': 'Roberto Pallini, MD, PhD', 'role': 'CONTACT', 'email': 'roberto.pallini@unicatt.it', 'phone': '+39 06 3015 5414'}, {'name': 'Rina Di Bonaventura, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Q. Giorgio D'Alessandris, MD", 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Alessandro Olivi, MD', 'role': 'CONTACT', 'email': 'alessandro.olivi@policlinicogemelli.it', 'phone': '+39 06 3015 4120'}, {'name': 'Rina Di Bonaventura, MD', 'role': 'CONTACT', 'email': 'rina.dibonaventura@guest.policlinicogemelli.it', 'phone': '+39 06 3015 1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}