Patient experiences during treatment for IDH‑mutant grade 2 gliomas: vorasidenib, radiotherapy, or observation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with histologically confirmed IDH‑mutant grade 2 gliomas who are managed with vorasidenib, radiotherapy, or active surveillance. Participants are grouped by their real‑world treatment pathway and complete patient‑reported outcome measures every six months for two years. The study tracks quality of life, treatment‑related symptoms, and anxiety, and evaluates the feasibility of routinely using PROMs in clinical practice. Collected responses will be analyzed to identify critical patient‑reported issues and inform improvements in care pathways at the participating center in Milan.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione IRCCS Istituto Neurologico Carlo Besta
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Sara Morlino, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
• Study coordinator: Cristiana Pedone, MD
• Email: cristiana.pedone@istituto-besta.it
• Phone: + 02 2394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.