protocolSection identificationModule nctId: NCT06348693, orgStudyIdInfo id: Gliotherapy, briefTitle: Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness, statusModule overallStatus: RECRUITING, startDateStruct date: 2017-04-19, primaryCompletionDateStruct date: 2025-11-21, completionDateStruct date: 2025-11-21, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment., conditionsModule conditions: Glioblastoma, conditions: Glioma, conditions: Glioma Glioblastoma Multiforme, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: cell isolation from tumor biopsies and biomarker investigation, outcomesModule primaryOutcomes measure: Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis., secondaryOutcomes measure: Biomarker investigation, secondaryOutcomes measure: Cellular response to pharmacological treatments, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Stefania E Navone, PhD, role: CONTACT, phone: 0255034268, phoneExt: +39, email: stefania.navone@policlinico.mi.it, contacts name: Giovanni Marfia, MD, PhD, role: CONTACT, phone: 0255034268, phoneExt: +39, email: giovanni.marfia@policlinico.mi.it, contacts name: Stefania Navone, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Marfia, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Guarnaccia, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Begani, MSc, role: SUB_INVESTIGATOR, contacts name: Marco Locatelli, Md, PhD, role: SUB_INVESTIGATOR, contacts name: Claudia Fanizzi, MD, role: SUB_INVESTIGATOR, contacts name: Luigi Schisano, MD, role: SUB_INVESTIGATOR, contacts name: Antonella Ampollini, MD, role: SUB_INVESTIGATOR, contacts name: Manuela Caroli, MD, role: SUB_INVESTIGATOR, contacts name: Giulio Bertani, MD, role: SUB_INVESTIGATOR, contacts name: Giorgio Fiore, MD, role: SUB_INVESTIGATOR, contacts name: Antonio D Ammando, MD, role: SUB_INVESTIGATOR, contacts name: Elena Scagliotti, MSc, role: SUB_INVESTIGATOR, contacts name: Giorgia Abete Fornara, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False