Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared (LGG PRO's)

April 17, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
vorasidenib: patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
Drug: Vorasidenib
patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
Group 2
Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
Procedure: Radiotherapy
Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
Group 3
Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.
Procedure: active surveillance
Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas
Time Frame: 3 years

To characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas through the administration of PROs across different settings: radiotherapy, medical oncology, and in the absence of adjuvant treatments.

Use of standardized questionnaires 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Sara Morlino, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LGG PRO's

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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