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Recruiting NCT07547163

Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared

Conditions: Glioma Glioma of Brain Low Grade Glioma of Brain Low Grade Gliomas IDH Mutation

Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

trial.available_in: БГ
Overview
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. To 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. To assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.
Description
Patients with IDH-mutant grade 2 gliomas whose therapeutic pathway is defined according to clinical practice. They are divided into three groups: * patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor; * patients treated with radiotherapy for residual disease or recurrence; * patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation. These patients are asked to complete the questionnaires every 6 months for two years, regardless of the ongoing clinical pathway.
Who can participate
Inclusion Criteria: * Age \> 18 years * Histological diagnosis of IDH mutant, grade 2 glioma * Consent to treatment * Consent to the administration of PROM questionnaires Exclusion Criteria: * Cognitive impairment or mental disability. * Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable. * Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses. * Language barriers. * 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. * Literacy issues: participants who are unable to read or write are excluded. * Non-adherence or poor cooperation. * 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. * Conditions that may influence questionnaire outcomes. * 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.
Interventions
Vorasidenib
DRUG
Radiotherapy
PROCEDURE
active surveillance
PROCEDURE
Locations 1
Italy (1)
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.04.2025
Completion date
01.10.2027
Registry ID
NCT07547163
Source
clinicaltrials.gov
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