Actively Recruiting

Age: 18Years +
All Genders
NCT07547163

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

Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-04-23

90

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Histological diagnosis of IDH mutant, grade 2 glioma
  • Consent to treatment
  • Consent to the administration of PROM questionnaires
Not Eligible

You will not qualify if you...

  • Cognitive impairment or mental disability
  • Dementia or severe cognitive disorders preventing understanding of questionnaires
  • Uncontrolled severe psychiatric disorders such as schizophrenia or untreated psychosis
  • Language barriers or inability to understand the questionnaire language
  • Literacy issues preventing reading or writing
  • Non-adherence or poor cooperation
  • Refusal to complete the questionnaires
  • Conditions that may influence questionnaire outcomes
  • Use of medications that impair cognitive abilities such as sedatives or antipsychotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Actively Recruiting

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Research Team

C

Cristiana Pedone, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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