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Набира участници NCT07547163

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

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

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

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Интервенции
Vorasidenib
DRUG
Radiotherapy
PROCEDURE
active surveillance
PROCEDURE
Места на провеждане 1
Италия (1)
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.04.2025
Крайна дата
01.10.2027
Регистрационен номер
NCT07547163
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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