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Patients' voices heard: comparing brain tumor treatments through their eyes

NCT ID NCT07547163

Knowledge-focused Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how people with a slow-growing brain tumor (low-grade glioma) feel during different treatments. Researchers will ask 90 patients about their quality of life, symptoms, and anxiety while they receive either the drug vorasidenib, radiotherapy, or just regular check-ups. The goal is to learn which approach is easier on patients, helping doctors make better care decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vorasidenib
What this could lead to
If successful, this could help doctors understand which treatment—vorasidenib, radiotherapy, or just monitoring—better preserves quality of life for people with low-grade gliomas.
What could go wrong
This is an observational study, not a treatment trial, so it won't prove which therapy is more effective. Results may not apply to all patients, and questionnaires may not capture every side effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult population with LGG diagnosis receiving radiotherapy, vorasidenib or follow-up

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

astrocytoma, IDH-mutant, grade 2 brain glioma glioma low grade glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GLIOMA Glioma of brain IDH mutation Low grade glioma of brain Low grade gliomas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, Italy

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