Patient experiences during treatment for IDH‑mutant grade 2 gliomas: vorasidenib, radiotherapy, or observation
Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared
This project will test how adults with IDH‑mutant grade 2 gliomas feel—their quality of life, treatment symptoms, and anxiety—when they receive vorasidenib, radiotherapy, or active surveillance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07547163 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 with a histological diagnosis of IDH‑mutant grade 2 glioma who can give consent and reliably complete questionnaires are ideal candidates.
Not a fit: Patients who cannot read or understand the questionnaire language, have severe cognitive impairment or uncontrolled psychiatric disorders, or who refuse to complete PROMs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the project could help clinicians better understand and manage symptoms and anxiety related to different care pathways, improving patient‑centered care and quality of life.
How similar studies have performed: Patient‑reported outcome measures are increasingly used in oncology and have informed care in other brain tumor populations, but directly comparing PROMs across vorasidenib, radiotherapy, and observation in IDH‑mutant grade 2 gliomas is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.