[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495163":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":41,"locations":49,"responsibleParty":85,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":22,"enrollmentInfo":101,"targetDuration":22,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":22,"overallStatus":52,"whyStopped":22,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Primary brain and skull-base tumors","Primary brain and skull-base tumors who are amenable for radiotherapy (photon or proton therapy) will all be examined with neurocognitive tests, questionnaires and advanced MR imaging",[12,13,14,15],"Behavioral: Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test","Diagnostic Test: MRI","Behavioral: Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI","Other: Toxicity scoring",[17,23,28,32],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BEHAVIORAL","Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test","Primary brain tumour patients will be evaluated longitudinally at the following timepoints: baseline (minimal 4 weeks after surgery, before radiotherapy), three months after end of radiotherapy, 1 year after end of radiotherapy and 2 years after end of radiotherapy. At each visit, neurocognitive testing, a self-report inventory and\u002For advanced MR imaging will take place.\n\nTime points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DIAGNOSTIC_TEST","MRI","Advanced MRI: all participants will be scanned on a 3T Siemens of Philips MR scanner (multicenter protocol): MPRAGE, FLAIR, T2, DWI, rsfMRI, SWI \\& ASL\n\nTime points: baseline, 3 months post-radiotherapy and 12 months post-radiotherapy",[9],{"type":18,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI","Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy",[9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":22},"Toxicity scoring","During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.",[9],[37],{"name":38,"affiliation":39,"role":40},"Maarten Lambrecht, MD PhD","UZ Leuven","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":22,"email":46},"Laurien De Roeck, MD","CONTACT","016 34 76 00","Laurien.deroeck@uzleuven.be",{"name":38,"role":44,"phone":45,"phoneExt":22,"email":48},"Maarten.lambrecht@uzleuven.be",[50,65,74],{"facility":51,"status":52,"city":53,"state":22,"zip":22,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Hospitals Ghent","RECRUITING","Ghent","Belgium","BE",{"type":57,"coordinates":58},"Point",[59,60],3.71667,51.05,{"lat":60,"lon":59},[63],{"name":64,"role":44,"phone":22,"phoneExt":22,"email":22},"Tom Boterberg, MD PhD",{"facility":39,"status":52,"city":66,"state":22,"zip":22,"country":54,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Leuven",{"type":57,"coordinates":68},[69,70],4.70093,50.87959,{"lat":70,"lon":69},[73],{"name":38,"role":44,"phone":22,"phoneExt":22,"email":22},{"facility":75,"status":52,"city":76,"state":22,"zip":22,"country":54,"countryCode":55,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Gasthuis Zusters Antwerpen","Wilrijk",{"type":57,"coordinates":78},[79,80],4.39513,51.16734,{"lat":80,"lon":79},[83],{"name":84,"role":44,"phone":22,"phoneExt":22,"email":22},"Katrien Erven, MD PhD",{"type":86,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[88,90],{"name":89,"class":6},"University Hospital, Ghent",{"name":75,"class":6},"100495163","neurocognition-after-radiotherapy-in-cns--and-skull-base-tumors-100495163",false,"NCT05727605","Neurocognition After Radiotherapy in CNS- and Skull-base Tumors","Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors","NARCiS","Inclusion Criteria:\n\n* Adult patients (≥ 18 years at the time of diagnosis) with a primary brain or base of skull tumour, who are amenable for conventionally fractionated radiotherapy (photon or proton irradiation)\n\nExclusion Criteria:\n\n* Patients with tumours with poor prognostic characteristics:\n\n  * Incompletely resected IDH-wild-type glioma\n  * Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma\n  * grade III meningioma\n  * H3K27M+ midline glioma\n* Patients with tumours requiring craniospinal irradiation (CSI)\u002Fwhole ventricular irradiation (WVI)\n* Hypofractionated\u002Fstereotactic radiation (fraction sizes \\> 2 Gy per fraction)\n* Inability to perform the cognitive tests or self-report inventories because of motor\u002Fsensory deficits or insufficient Dutch language proficiency\n* Mental retardation documented before diagnosis\n* Pre-diagnosis\u002Fpre-existing psychiatric diagnosis resulting in cognitive deficits like psychoses, neurodevelopmental disorders (autism\u002Flearning disorders)\n* Relapse previously treated by chemo and\u002For radiation therapy\n* Genetic syndrome (e.g. Down)\n* Unable to perform MR imaging (claustrophobia, metallic implants like pacemaker\u002FICD\u002Fneurostimulator)","ALL","18 Years",{"count":102,"type":103},120,"ESTIMATED","INTERVENTIONAL",[106],"NA","The goal of this multicenter prospective longitudinal study is to study the long-term impact of multimodal treatment (chemotherapy, radiotherapy and surgery) in adult brain and base of skull tumors on neurocognitive functioning.\n\nAll included patients will complete a self-report inventory (subjective cognitive functioning, QoL, confounders), a cognitive test battery, an advanced MR at multiple timepoints. Moreover, toxicity will be scored according to the CTCAEv5.0 in these patients over time.",[109,110,111,112,113,114],"Cognition","Brain Tumor","Magnetic Resonance Imaging","Meningioma","Glioma","Pituitary Adenoma","2024-05-07",{"date":117,"type":118},"2024-05-08","ACTUAL",{"date":120,"type":118},"2023-02-08",{"date":122,"type":103},"2027-02-01",{"name":5,"class":6},3]