[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577164":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":28,"armGroups":29,"interventions":25,"overallOfficials":25,"centralContacts":36,"locations":44,"responsibleParty":101,"collaborators":103,"id":109,"slug":25,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":25,"enrollmentInfo":117,"targetDuration":120,"studyType":121,"phases":25,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":91,"whyStopped":25,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression Free Survival (PFS)","time from surgery to evidence of radiological progression at MRI","(up to 180 months)",{"measure":14,"description":15,"timeFrame":12},"Overall Survival (OS)","Time from surgery to tumor-related death",[17,21],{"measure":18,"description":19,"timeFrame":20},"Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1\u002F2, ATRX and 1p\u002F19q chromosomal deletion)","Astrocytoma vs Oligodendroglioma (integration of immunohistochemistry and molecular evaluation of IDH1\u002F2, ATRX and 1p\u002F19q chromosomal deletion)","From date of surgery to date of complete diagnosis (weeks)",{"measure":22,"description":23,"timeFrame":24},"Tumor Grade at histology and molecular analysis (CDKN2A\u002FB deletion)","Tumor grade upon histology and molecular analysis (CDKN2A\u002FB deletion)","From surgery to complete history-molecular diagnosis (weeks)",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":6,"maskingInfo":25},"COHORT","Patients affected by brain lower grade gliomas who access Neurosurgery Department (OR, ER, outpatient clinic) at IRCCS Ospedale Galeazzi Sant'Ambrogio and Policlinico Bari, or Oncology Department at Ospedale San Paolo Bari",[30,33],{"label":31,"type":25,"description":32,"interventionNames":25},"Prospective Metabolic Cohort","Patients operated on for lower grade gliomas from whom part of the exceeding pathologic material will be collected for metabolomic profiling",{"label":34,"type":25,"description":35,"interventionNames":25},"Retrospective FFPE Sample Cohort","Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available.",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Lorenzo Bello, MD","CONTACT","+390283502228","direzionescientifica.ogsa@grupposandonato.it",{"name":43,"role":39,"phone":40,"phoneExt":25,"email":41},"Direzione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano",[45,66,78,89],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Ospedale San Paolo Bari","NOT_YET_RECRUITING","Bari","Apulia","70123","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],16.86982,41.12066,{"lat":57,"lon":56},[60,64],{"name":61,"role":39,"phone":62,"phoneExt":25,"email":63},"Valeria Internò, MD","+390805843721","valeria.interno@libero.it",{"name":61,"role":65,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"facility":67,"status":47,"city":48,"state":49,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Policlinico Bari University Hospital (Bari, Italy)","70124",{"type":54,"coordinates":70},[56,57],{"lat":57,"lon":56},[73,77],{"name":74,"role":39,"phone":75,"phoneExt":25,"email":76},"Francesco Signorelli, MD","+39805597054","francesco.signorelli@uniba.it",{"name":74,"role":65,"phone":25,"phoneExt":25,"email":25},{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":51,"countryCode":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":25},"Università Vita-Salute San Raffaele","ACTIVE_NOT_RECRUITING","Milan","Lombardy","20132",{"type":54,"coordinates":85},[86,87],9.18951,45.46427,{"lat":87,"lon":86},{"facility":90,"status":91,"city":81,"state":82,"zip":92,"country":51,"countryCode":52,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"IRCCS Galeazzi-Sant'Ambrogio","RECRUITING","20157",{"type":54,"coordinates":94},[86,87],{"lat":87,"lon":86},[97,99],{"name":98,"role":39,"phone":40,"phoneExt":25,"email":41},"Direzione Scientifica",{"name":38,"role":100,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":102,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[104,105,107],{"name":79,"class":6},{"name":106,"class":6},"University of Bari",{"name":46,"class":108},"UNKNOWN","100577164",false,"NCT06794736","STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)","STRADIVARI","Prospective Metabolic Cohort:\n\nInclusion Criteria:\n\n* Radiological diagnosis of brain tumor compatible with lower grade glioma\n* Full clinical history\n\nExclusion Criteria:\n\n* Current pregnancy or lactation\n* Patients not able to provide informed consent\n\nRetrospective Cohort of FFPE samples:\n\nInclusion Criteria:\n\n* Confirmed diagnosis of lower grade glioma\n* Full clinical and radiological history","ALL","18 Years",{"count":118,"type":119},110,"ESTIMATED","6 Months","OBSERVATIONAL","The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility.\n\nParticipants of prospective metabolic cohort will be subjected to routine treatment, part of the exceeding tutor material will be subjected to advanced molecular-metabolic analyses to desume their metabolic profile to be then correlated with clinical outcome (progression-free survival, overall survival, response to therapy\u002Fprogression) and diagnosis (astrocytoma\u002Foligodendroglioma and grade).\n\nCritical enzymes identified from metabolic analyses on the first cohort will be tested on a protein level on a retrospective cohort of patients previously operated and for whom fully available clinical history and pathological material is available in Institutional archive (no need for further intervention on these patients) to see if they actually correlate with clinical outcome.",[124],"Lower Grade Glioma",[126,127,128,129],"Lower grade glioma","Metabolomics","Tumor heterogeneity","Patient Stratification","2025-01-22",{"date":132,"type":133},"2025-01-27","ACTUAL",{"date":135,"type":133},"2024-11-14",{"date":137,"type":119},"2026-08",{"name":5,"class":6},4]