[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100367605":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":28,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Proton Therapy",null,"Patients receive proton Radio(chemo)therapy according to clinical standard. Proton Treatment is indicated BEFORE inclusion into the trial ans is not part of the trial. Neurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely during follow-up using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases. In addition to the treatment parameters of the radio(chemo)therapy protocol, further radiation doses to brain substructures and organs at risk are documented.",{"label":13,"type":10,"description":14,"interventionNames":10},"No Radiotherapy - Surgical only group","Patients are included AFTER surgery of their brain tumour and receive no radiotherapy due to their disease (i.e. according to clinical standard). This Treatment is not part of the trial, but stratifies the Patient in this second Group.\n\nNeurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely during follow-up using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases.",{"label":16,"type":10,"description":17,"interventionNames":10},"Control Group","Healthy kids are recruited as Standard Group.\n\nNeurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases.",[19],{"name":20,"affiliation":21,"role":22},"Mechthild Krause, Prof. Dr.","University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)","STUDY_CHAIR",[24],{"name":20,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","+49 351 458 2238","mechthild.krause@uniklinikum-dresden.de",[29,46,54],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy","RECRUITING","Dresden","Saxony","01307","Germany","DE",{"type":38,"coordinates":39},"Point",[40,41],13.73832,51.05089,{"lat":41,"lon":40},[44],{"name":45,"role":25,"phone":10,"phoneExt":10,"email":10},"Christian Beste, Prof. Dr.",{"facility":47,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics",{"type":38,"coordinates":49},[40,41],{"lat":41,"lon":40},[52],{"name":53,"role":25,"phone":10,"phoneExt":10,"email":10},"Maja von der Hagen, Prof. Dr.",{"facility":55,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology",{"type":38,"coordinates":57},[40,41],{"lat":41,"lon":40},[60],{"name":20,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[64],{"name":65,"class":66},"Gert und Susanna Mayer Stiftung","UNKNOWN","100367605","neurocognitive-function-after-proton-therapy-in-children-and-adolescents-100367605",false,"NCT04066465","Neurocognitive Function After Proton Therapy in Children and Adolescents","Neurocognitive Function \u002Fexecutive Functions After Proton Therapy in Children and Adolescents.","ELBE-ProKids","Indication: Patients with primary brain tumor\n\nInclusion Criteria:\n\n* all groups: Patients in childhood and adolescence between 8-18 years of age\n* all groups: no prior radiotherapy of the brain,\n* all groups: The patient is able to perform repeated neuropsychological tests (approx. 1 hour per examination),\n* all groups: corrected visual acuity not impaired below 80% or no subjective indication of visual acuity impairment,\n* all groups: corrected hearing not impaired or no subjective evidence of hearing impairment,\n* all groups: Patient is able to perform follow-up examinations,\n* all groups: written consent of the patient\u002Fparent or guardian.\n* Brain tumour groups with\u002Fwithout irradiation: Primary brain tumour\n* brain tumor groups with\u002Fwithout radiation: curative or long-term palliative intention of therapy\n* brain tumor groups with\u002Fwithout irradiation: life expectancy \\> 3 years\n* Irradiation group only: planned proton therapy with a local radiation dose of at least 40 Gy(RBE)\n\nExclusion Criteria:\n\n* Patients under 8 or over 18 years of age (We limit the study to children over 8 years of age due to the fact that executive functions mature very late.)\n* Brain metastases from extracerebral tumors\n* Patient receives intrathecal chemotherapy\n* pure palliative treatment concept\n* The patient is not able to perform repeated neuropsychological tests (approx. 1 hour per examination).\n* Chronic diseases that may affect the results of neurological EEG and neuropsychological examinations.\n* The patient is not in a position to perform follow-up examinations\n* no written consent of the patient \u002F parent or legal guardian\n* Participation in an intervention study whose procedures contradict those of the present study",true,"ALL","8 Years","18 Years",{"count":80,"type":81},90,"ESTIMATED","OBSERVATIONAL","Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted\u002Fanalysed\u002Fevalutated. In a second step, these results are to be compared with\n\n1. a group of children and adolescents who had only \u002Fexclusively had operative therapy and\n2. with a healthy control group. Thus, the extent to which these treatment options differ in terms of their short and medium-term effect is assessed. Methods of neurocognitive\u002Fneurophysiology brain research approaches are applied that may potentially visualize even small \u002F subtle changes in mental activities\u002Fneurocognitive function. Therefore the effects of treatment can be evaluated and the neuropsychological outcome of children and adolescents with brain tumors can be improved.",[85],"Primary Brain Tumor",[87,88,89,90,91,92,93,9,94],"Brain Tumor","children and adolescents","neurocognitive function","neurocognitive or neuropsychological outcome","quality of life, LOQ","EEG","Neuropsychological Tests","Neurosurgical Treatment","2025-02-04",{"date":97,"type":98},"2025-02-06","ACTUAL",{"date":100,"type":98},"2019-09-01",{"date":102,"type":81},"2027-12-31",{"name":5,"class":6},3]