[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595180":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":13,"centralContacts":33,"locations":43,"responsibleParty":80,"collaborators":13,"id":82,"slug":13,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":13,"enrollmentInfo":90,"targetDuration":13,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":102,"whyStopped":13,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Centre Henri Becquerel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Ex-vivo organoid culture feasability","Proportion (in number of patients) of phenotypically and molecularly exploitable tumor and vascular organoid models (GBO+BVO) seven days after diagnostic neurosurgical removal (complete or partial excision) in patients with glioblastoma","7 days",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","The ORGA-GLIO study will be conducted in two stages:\n\nFirst stage: Establishment of the clinical-biological collection and addressing the primary objective.\n\nStep 1: Generation of tumor organoids (Glioblastoma Organoids - GBO), vascular organoids (Blood Vessel Organoids - BVO), and cell lines.\n\nStep 2: Phenotypic and molecular analyses of tumor and vascular organoids up to 7 days.\n\nSecond stage: Utilization of the biological collection of organoids and blood samples.\n\nUtilization of the organoid collection and investigation of associations between the molecular and phenotypic and clinical and survival data collected during patient follow-up visits.\n\nCorrelation of organoid evolution under experimental treatment procedure and evolution of plasma-based biomarker from corresponding patients and along first-line treatment schedule.\n\nAll patients will be planned to receive standard of care for glioblastoma after resection, namely radiotherapy+temozolomide and TTFields.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Ex-vivo Organoid culture","EXPERIMENTAL","ex-vivo organoid culture after tumor resection",[27],"Other: Ex-vivo organoid culture",[29],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":13},"Ex-vivo organoid culture","ex-vivo organoid cultures composed of tumor cells within their microenvironment (glioblastoma organoid - GBO) and intra- and peri-tumoral blood vessels (blood vessel organoid - BVO), derived from perioperative samples obtained during complete or partial surgical resection",[23],[34,39],{"name":35,"role":36,"phone":37,"phoneExt":13,"email":38},"Maxime Fontanille, MD,PhD","CONTACT","+33276673091","maxime.fontanilles@chb.unicancer.fr",{"name":40,"role":36,"phone":41,"phoneExt":13,"email":42},"Doriane Richard, PhD","+33232082985","doriane.richard@chb.unicancer.fr",[44,60,70],{"facility":45,"status":13,"city":46,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Groupe Hospitalier du Havre","Le Havre","France","FR",{"type":50,"coordinates":51},"Point",[52,53],0.10785,49.49346,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":58,"phoneExt":13,"email":59},"Marine Lacaud","+332 32 73 32 32","marine.lacaud@ch-havre.fr",{"facility":5,"status":13,"city":61,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Rouen",{"type":50,"coordinates":63},[64,65],1.09932,49.44313,{"lat":65,"lon":64},[68],{"name":69,"role":36,"phone":37,"phoneExt":13,"email":38},"Maxime Fontanilles",{"facility":71,"status":13,"city":61,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"CHU Rouen",{"type":50,"coordinates":73},[64,65],{"lat":65,"lon":64},[76],{"name":77,"role":36,"phone":78,"phoneExt":13,"email":79},"Olivier Langlois","+33232888042","olivier.langlois@chu-rouen.fr",{"type":81,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100595180",false,"NCT07029100","Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.","ORGA-GLIO","Inclusion Criteria:\n\n* Patient, male or female, adult (age ≥ 18 years),\n* Suspected of having a high-grade glioma based on preoperative multimodal MRI,\n* With an indication for tumor resection surgery,\n* And in a clinical condition suitable to undergo adjuvant treatment consisting of radiotherapy (normo- or hypo-fractionated) combined with temozolomide, with or without low-frequency electric fields (Tumor-Treating Fields®).\n\nExclusion Criteria:\n\n* Current tumor pathology or history of tumor pathology in remission for less than 2 years\n* Pregnant or breastfeeding women,\n* Patients unable to understand the study for any reason or unable to comply with trial requirements (language barriers, psychological or geographical issues, etc.).","ALL","18 Years",{"count":91,"type":92},30,"ESTIMATED","INTERVENTIONAL",[15],"The main goal of ORGA-GLIO trial is to establish the feasibility in routine clinical practice of ex-vivo organoid cultures composed of tumor cells within their microenvironment (glioblastoma organoid - GBO) and intra- and peri-tumoral blood vessels (blood vessel organoid - BVO), derived from perioperative samples obtained during complete or partial surgical resection in patients with newly diagnosed glioblastoma.",[97],"Glioblastoma",[99,100,101],"glioblastoma","organoide","molecular analysis","NOT_YET_RECRUITING","2025-06-18",{"date":105,"type":106},"2025-06-19","ACTUAL",{"date":108,"type":92},"2025-07-01",{"date":110,"type":92},"2029-07-01",{"name":5,"class":6},3]