[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635013":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":10,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":10,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1",null,"vorasidenib: patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;",[13],"Drug: Vorasidenib",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2","Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;",[18],"Procedure: Radiotherapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3","Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.",[23],"Procedure: active surveillance",[25,30,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DRUG","Vorasidenib","patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;",[9],{"type":31,"name":32,"description":16,"armGroupLabels":33,"otherNames":10},"PROCEDURE","Radiotherapy",[15],{"type":31,"name":35,"description":21,"armGroupLabels":36,"otherNames":10},"active surveillance",[20],[38],{"name":39,"affiliation":40,"role":41},"Sara Morlino, MD","Fondazione IRCCS Istituto Neurologico Carlo Besta","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":10,"email":47},"Cristiana Pedone, MD","CONTACT","+ 02 2394","cristiana.pedone@istituto-besta.it",[49],{"facility":40,"status":50,"city":51,"state":10,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Milan","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],12.59836,42.78235,{"lat":58,"lon":57},[61,63],{"name":44,"role":45,"phone":62,"phoneExt":10,"email":47},"+ 39 02.2394",{"name":39,"role":45,"phone":64,"phoneExt":10,"email":65},"0039.02.2394","sara.morlino@istituto-besta.it",{"type":67,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100635013","patient-voice-in-the-treatment-of-low-grade-gliomas-use-of-patient-reported-outcomes-vorasidenib-and-radiotherapy-compared-100635013",false,"NCT07547163","Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared","LGG PRO's","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological diagnosis of IDH mutant, grade 2 glioma\n* Consent to treatment\n* Consent to the administration of PROM questionnaires\n\nExclusion Criteria:\n\n* Cognitive impairment or mental disability.\n* Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable.\n* Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses.\n* Language barriers.\n* Inability to understand the language of the questionnaire: participants who do not speak or understand the language in which the questionnaire is written are excluded if validated translations are not available.\n* Literacy issues: participants who are unable to read or write are excluded.\n* Non-adherence or poor cooperation.\n* Refusal to complete the questionnaires: even if the patient agrees to participate in the study, the specific refusal to complete the questionnaires leads to exclusion.\n* Conditions that may influence questionnaire outcomes.\n* Use of medications that impair cognitive abilities: the use of sedatives or antipsychotics may affect the ability to provide coherent responses, compromising the validity of PROs.","ALL","18 Years",{"count":78,"type":79},90,"ESTIMATED","OBSERVATIONAL","The study aims to assess the direct patient-reported perception (PROs) of individuals affected by IDH-mutant, grade 2 gliomas undergoing radiotherapy or pharmacological treatment with vorasidenib.\n\nTo evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.\n\nTo assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.",[83,84,85,86,87],"Glioma","Glioma of Brain","Low Grade Glioma of Brain","Low Grade Gliomas","IDH Mutation",[89,90,86,91,92],"Patient Reported Outcomes","glioma","grade 2 glioma","IDH mutant","2026-04-17",{"date":95,"type":96},"2026-04-23","ACTUAL",{"date":98,"type":96},"2025-04-23",{"date":100,"type":79},"2027-10",{"name":5,"class":6},1]