- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286929
Evaluation of the Variation Over Time of Visuospatial Deficit in Patients With Parietal Lobe Glioma (neGLIO)
December 3, 2025 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
The goal of modern neurooncological surgery is to obtain maximum tumor resection while preserving neurological function.
Parietal lobe gliomas often cause attention deficits (hemineglect) that are difficult to differentiate from other deficits.
This study aims to evaluate the extent and variation over time of visuo-spatial deficits in patients undergoing surgical removal of parietal lobe gliomas.
This will help characterize the cognitive profile of these patients to identify personalized treatment and rehabilitation paths.
Study Overview
Status
Recruiting
Detailed Description
This is a single-centre, prospective, cross-sectional, observational study involving 40 patients with high- and low-grade parietal lobe glioma.
The study investigates the prevalence of subjects who show a performance in cognitive visuo-spatial tests below the cut-off of the normative sample.
It evaluates associations with patient-reported outcome measures (ADL, IADL), clinical-demographic aspects, radiological data (MRI), and histological/molecular data.
Assessments occur at screening (pre-surgery), and at follow-up visits (3-4 months and 6 months post-surgery).
Neuropsychological tests include Line Bisection, Bell and Letter Cancellation, Reading test, Apple Cancellation, and Fluff test.
Study Type
Observational
Enrollment (Estimated)
40
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
- Name: Francesco Di Meco, MD
- Phone Number: + 39 02.2394
- Email: francesco.dimeco@istituto-besta.it
Study Locations
-
-
-
Milan, Italy
- Recruiting
- Fondazione IRCCS Istituto Neurologico Carlo Besta
-
Contact:
- Francesco Di Meco, MD
- Phone Number: + 39 02.2394
- Email: francesco.dimeco@istituto-besta.it
-
-
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
Patients with suspected parietal lobe glioma
Description
Inclusion Criteria:
- Patients >18 years old
- Patients must understand the Italian Language
- Patients with suspected parietal lobe glioma
Exclusion Criteria:
- Tumor site other than parietal lobe.
- Patients who cannot undergo surgical resection (stereotactic/open biopsy).
- Patients who received a previous chemotherapy and/or radiotherapy treatment.
- Patients with a history of intracranial mass lesion or traumatic brain injury.
- Patients with a history of other CNS diseases (e.g., stroke, metastasis).
- Patients with diagnosis of neurodegenerative disease (i.e. Alzheimer's Disease, Frontotemporal Dementia, Parkinson's Disease, Lewy Body Dementia, Amyotrophic Lateral Sclerosis).
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Visuospatial Deficit Prevalence
Time Frame: Baseline (pre-surgery), 3-4 months post-surgery, 6 months post-surgery.
|
Prevalence of patients with a score below the cut-off in specific neuropsychological tests for visuo-spatial aspects (Line Bisection, Bell/Letter Cancellation, Apple Cancellation, Fluff Test) and the extent of change compared to baseline.
|
Baseline (pre-surgery), 3-4 months post-surgery, 6 months post-surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association with Radiological Data
Time Frame: Up to 6 months post-surgery
|
Correlation between visuo-spatial deficit scores and MRI data (FLAIR volume, T1 contrast, necrosis, localization).
|
Up to 6 months post-surgery
|
|
Association with Clinical-Demographic Data
Time Frame: Up to 6 months post-surgery.
|
Correlation between visuo-spatial scores and hemispheric dominance, age, sex, and education.
|
Up to 6 months post-surgery.
|
|
Association with Performance Status
Time Frame: Time Frame: Up to 6 months post-surgery.
|
Correlation between visuo-spatial scores and Karnofsky Performance Status (KPS).
|
Time Frame: Up to 6 months post-surgery.
|
|
Association with Histological/Molecular Data
Time Frame: Up to 6 months post-surgery.
|
Correlation between visuo-spatial scores and tumor grade, histological and molecular features.
|
Up to 6 months post-surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francesco Di Meco, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta
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)
December 3, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
December 3, 2025
First Submitted That Met QC Criteria
December 3, 2025
First Posted (Actual)
December 16, 2025
Study Record Updates
Last Update Posted (Actual)
December 16, 2025
Last Update Submitted That Met QC Criteria
December 3, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- neGLIO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Glioma
-
University of California, San FranciscoPacific Pediatric Neuro-Oncology ConsortiumRecruitingPediatric Cancer | Low-grade Glioma | Low Grade Glioma of Brain | Recurrent Low Grade GliomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI); Food and Drug Administration (FDA)Active, not recruitingRecurrent Glioblastoma | Recurrent Malignant Glioma | Refractory Malignant Glioma | Recurrent WHO Grade III Glioma | Recurrent WHO Grade II Glioma | Refractory Glioblastoma | Refractory WHO Grade II Glioma | Refractory WHO Grade III GliomaUnited States
-
Children's Hospital of PhiladelphiaBlue Earth Diagnostics; Dragon Master FoundationRecruitingGlioma | Low-grade Glioma | Glioma, Malignant | Low Grade Glioma of Brain | Glioma IntracranialUnited States
-
Children's Hospital of PhiladelphiaBlue Earth Diagnostics; Dragon Master FoundationRecruitingGlioma | High Grade Glioma | Glioma, Malignant | Diffuse Glioma | Glioma IntracranialUnited States
-
ChimerixOncoceutics, Inc.TerminatedGlioblastoma | Diffuse Midline Glioma | H3 K27M Glioma | Thalamic Glioma | Infratentorial Glioma | Basal Ganglia GliomaUnited States
-
Ohio State University Comprehensive Cancer CenterRecruitingWHO Grade 3 Glioma | Recurrent Malignant Glioma | WHO Grade 2 Glioma | Recurrent WHO Grade 3 Glioma | Recurrent WHO Grade 4 Glioma | WHO Grade 4 GliomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGlioblastoma | Malignant Glioma | WHO Grade III Glioma | Recurrent Glioma | Refractory GliomaUnited States
-
University of California, San FranciscoBeiGene USA, Inc.Active, not recruitingGlioblastoma | Malignant Glioma | Recurrent Glioblastoma | Recurrent WHO Grade III Glioma | WHO Grade III Glioma | IDH2 Gene Mutation | IDH1 Gene Mutation | Low Grade Glioma | Recurrent WHO Grade II Glioma | WHO Grade II GliomaUnited States
-
Sabine Mueller, MD, PhDNot yet recruitingGlioblastoma | Diffuse Midline Glioma, H3 K27M-Mutant | High-grade Glioma | High-Grade Glioma (WHO III-IV) | Diffuse Hemispheric Glioma, H3G34 MutantUnited States
-
National Cancer Institute (NCI)SuspendedGlioma | High Grade Glioma | Malignant Glioma | Gliomas | Low Grade GliomaUnited States