[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527358":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":147,"collaborators":151,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":10,"studyType":176,"phases":10,"briefSummary":177,"conditions":178,"keywords":184,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Tumor resection",null,[12],"Procedure: Tumor resection",{"label":14,"type":10,"description":14,"interventionNames":15},"Tumor biopsy",[16],"Procedure: Tumor biopsy",[18,22],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":10},"PROCEDURE","Maximal safe resection of the tumor",[9],{"type":19,"name":14,"description":23,"armGroupLabels":24,"otherNames":10},"Biopsy of the tumor",[14],[26],{"name":27,"affiliation":5,"role":28},"Jasper Gerritsen, MD PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","+31107036130","j.gerritsen@erasmusmc.nl",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Arnaud Vincent, MD PhD","+31107034211","a.vincent@erasmusmc.nl",[39,56,69,82,98,109,122,133],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of California, San Francisco","RECRUITING","San Francisco","California","94143","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-122.41942,37.77493,{"lat":51,"lon":50},[54],{"name":55,"role":31,"phone":10,"phoneExt":10,"email":10},"Mitchel Berger, MD PhD",{"facility":57,"status":41,"city":58,"state":59,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":48,"coordinates":62},[63,64],-71.05977,42.35843,{"lat":64,"lon":63},[67],{"name":68,"role":31,"phone":10,"phoneExt":10,"email":10},"Brian Nahed, MD",{"facility":70,"status":41,"city":71,"state":10,"zip":10,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University Hospital Leuven","Leuven","Belgium","BE",{"type":48,"coordinates":75},[76,77],4.70093,50.87959,{"lat":77,"lon":76},[80],{"name":81,"role":31,"phone":10,"phoneExt":10,"email":10},"Steven De Vleeschouwer, MD PhD",{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Technical University Munich","NOT_YET_RECRUITING","Munich","Bavaria","74076","Germany","DE",{"type":48,"coordinates":91},[92,93],11.57549,48.13743,{"lat":93,"lon":92},[96],{"name":97,"role":31,"phone":10,"phoneExt":10,"email":10},"Arthur Wagner, MD PhD",{"facility":99,"status":41,"city":100,"state":10,"zip":10,"country":88,"countryCode":89,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University Hospital Heidelberg","Heidelberg",{"type":48,"coordinates":102},[103,104],8.69079,49.40768,{"lat":104,"lon":103},[107],{"name":108,"role":31,"phone":10,"phoneExt":10,"email":10},"Christine Jungk, Dr. med.",{"facility":5,"status":41,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":48,"coordinates":116},[117,118],4.47917,51.9225,{"lat":118,"lon":117},[121],{"name":27,"role":31,"phone":10,"phoneExt":10,"email":10},{"facility":123,"status":41,"city":124,"state":10,"zip":10,"country":113,"countryCode":114,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Haaglanden Medical Center","The Hague",{"type":48,"coordinates":126},[127,128],4.29861,52.07667,{"lat":128,"lon":127},[131],{"name":132,"role":31,"phone":10,"phoneExt":10,"email":10},"Marike Broekman, MD PhD",{"facility":134,"status":84,"city":135,"state":10,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Inselspital Universitätsspital Bern","Bern","3010","Switzerland","CH",{"type":48,"coordinates":140},[141,142],7.44744,46.94809,{"lat":142,"lon":141},[145],{"name":146,"role":31,"phone":10,"phoneExt":10,"email":10},"Philippe Schucht, MD PhD",{"type":148,"investigatorFullName":149,"investigatorTitle":150,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Jasper Gerritsen","Jasper K.W. Gerritsen MD PhD",[152,154,156,157,159,161,162],{"name":153,"class":6},"Haaglanden Medical Centre",{"name":155,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":99,"class":6},{"name":158,"class":6},"Technical University of Munich",{"name":160,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":57,"class":6},{"name":40,"class":6},"100527358","the-resbiop-study-resection-versus-biopsy-in-high-grade-glioma-patients-encram-2202-100527358",false,"NCT06146725","The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)","RESBIOP","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Medical reasons precluding MRI (e.g. pacemaker)\n3. Inability to give written informed consent\n4. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n5. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin","ALL","18 Years","90 Years",{"count":174,"type":175},564,"ESTIMATED","OBSERVATIONAL","There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.",[179,180,181,182,183],"Glioblastoma","Glioblastoma, IDH-wildtype","Glioblastoma Multiforme","Glioblastoma Multiforme, Adult","Glioblastoma Multiforme of Brain",[185,186,187,188],"Resection","Biopsy","Survival","Quality of life","2023-11-18",{"date":191,"type":192},"2023-11-27","ACTUAL",{"date":194,"type":192},"2023-01-01",{"date":196,"type":175},"2029-01-01",{"name":149,"class":6},8]