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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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