Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 3:32 PM
Study NCT ID:
NCT05772767
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Ciliogenesis in Glioma Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cilia disassembly complex', 'Nek2', 'glioblastoma stem cells'], 'conditions': ['Glioblastoma', 'Glioma, Malignant']}, 'descriptionModule': {'briefSummary': 'The study aims at investigating the cilium-related transcriptome in patients-derived glioblastoma stem cells and the potential impact of modulation of cilium players in vitro, in vivo and ex vivo in glioblastoma brain organoids. Moreover, drugs inhibiting cilia disassembly will be tested. Finally, the potential prognostic role of a cilium-related gene expression signature in glioblastoma will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be enrolled in the study patients must:\n\n1. Have a radiological diagnosis of supratentorial glioblastoma, or\n2. Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had been made at first surgery), according with RANO criteria (Wen, 2010);\n3. Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery FPG;\n4. Be of an age of 18 years or above;\n5. Provide written informed consent for participation to the study.\n\nExclusion criteria\n\nTo be enrolled in the study patients must not:\n\n1. Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator;\n2. Have not a definitive pathological diagnosis of a primary supratentorial GBM, according with 2016 WHO classification.'}, 'identificationModule': {'nctId': 'NCT05772767', 'acronym': 'RF2019-1236878', 'briefTitle': 'Modulation of Ciliogenesis in Glioma Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Control of Growth and Invasiveness of Glioblastoma by Modulation of Ciliogenesis in Glioma Stem Cells. A Novel Target Against Glioblastoma for Precision Medicine. RF-2019-12368786', 'orgStudyIdInfo': {'id': '3782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Biological sample collection', 'description': 'Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.', 'interventionNames': ['Other: Biological sample collection', 'Other: Dissecting ciliogenesis players', 'Diagnostic Test: Validating ciliogenesis players']}], 'interventions': [{'name': 'Biological sample collection', 'type': 'OTHER', 'description': 'Collection of tumor tissue and blood for stem cell culture and organoids generation.', 'armGroupLabels': ['Biological sample collection']}, {'name': 'Dissecting ciliogenesis players', 'type': 'OTHER', 'description': 'Assessment of cilium-related transcriptome in glioblastoma stem cells. Modulation of cilium-related genes and administration of cilium-targeted drugs to glioblastoma stem cells in vitro and ex vivo in glioblastoma brain organoids.', 'armGroupLabels': ['Biological sample collection']}, {'name': 'Validating ciliogenesis players', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.', 'armGroupLabels': ['Biological sample collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Roberto Pallini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Superiore di Sanità ', 'class': 'OTHER'}, {'name': 'Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}