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RECRUITINGNA

Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma

Improving Personalised Glioblastoma Care by Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence Approaches

NCT05941234•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

The study aims at: 1. Perform a multilayer analysis relying on tight integration of in-depth multi-omics approaches with clinical data to discover immune markers, with attention to age and sex differences, predicting prognosis and defining key life/environmental elements, to guide AI-driven personalised treatments and ensure improved care and QoL of glioblastoma patients. 2. To deepen glioblastoma knowledge through the study of glioblastoma stem cell cultures and to assess the sensitivity of glioblastoma stem cell cultures to a number of chemotherapeutics in different experimental conditions. 3. To create a comprehensive, stakeholder-generated guidelines for the ethical use of patient data for artificial intelligence-assisted prediction systems in glioblastoma, including an online, easily accessible patient information brochure to increase patient empowerment in the field.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•To be enrolled in the study patients must:
•1. Have a radiological diagnosis of supratentorial glioblastoma, or
•2. Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with RANO criteria;
•3. Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery Fondazione Policlinico Gemelli IRCCS;
•4. Be of an age of 18 years or above;
•5. Provide written informed consent for participation to the study.

Exclusion Criteria

•To be enrolled in the study patients must not:
•1. Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator;
•2. Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2021 World Health Organization classification.

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy

Key Dates

Start Date

February 29, 2024

Primary Completion Date

May 30, 2026

Completion Date

December 30, 2026

Last Updated

March 13, 2025

Enrollment

120

ESTIMATED participants

Conditions

Glioblastoma, IDH-wildtype

Interventions

Biological biomarker analysis

OTHER

Contacts

Quintino Giorgio D'Alessandris, MD, PhD

CONTACT

+39 06 30155414 quintinogiorgio.dalessandris@policlinicogemelli.it

Roberto Pallini, MD, PhD

CONTACT

+39 06 30155414 roberto.pallini@unicatt.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma

Inclusion Criteria

Exclusion Criteria

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