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Starting soon Observational

Neurocognitive Integrity After Proton Therapy for Brain Tumor

NCT07836478 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-09
Last updated
2026-09-23

Condition(s) studied

Central Nervous System Tumour

Study summary

Radiation therapy remains a cornerstone in the management of both benign and malignant intracranial tumors, either as monotherapy or combined with surgery and/or chemotherapy. Despite its therapeutic benefits, it is frequently associated with potential long-term adverse effects, with neurotoxicity posing a major challenge, especially in young patients affected by benign primary tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Primary tumors of Brain Tumor (CNS), benign and malignant * Age ≥ 18 years * Patients able to speak and read the local language(s) fluently * Acceptance and signature of informed consent * Radiological diagnosis, biopsy, or previous surgery * Concomitant medical therapy is allowed Exclusion Criteria: * Previous brain radiotherapy (any form) * High-grade gliomas * Patients with concomitant neurological or psychiatric disorders. * Pregnancy

Primary outcome measure(s)

  • The presence of cognitive impairment — From the end of Protontherapy through study completion, an average of 1 year.
    The primary endpoint will be the presence of cognitive impairment during the first 5 years after enrollment, as measured by a comprehensive neuropsychological assessment.

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology, Milan Milan Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07836478 on ClinicalTrials.gov ↗ ← All trials in Italy