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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma, IDH-wildtype
• Intervention / Treatment: Other: Biological biomarker analysis

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quintino Giorgio D'Alessandris, MD, PhD; Phone Number: +39 06 30155414; Email: quintinogiorgio.dalessandris@policlinicogemelli.it
• Study Contact Backup: Name: Roberto Pallini, MD, PhD; Phone Number: +39 06 30155414; Email: roberto.pallini@unicatt.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Q. Giorgio D'Alessandris, MD; Phone Number: +390630155414; Email: quintinogiorgio.dalessandris@policlinicogemelli.it
    • Contact: Liverana Lauretti, MD; Phone Number: +390630155414; Email: liverana.lauretti@unicatt.it
    • Sub-Investigator: Martina Offi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients cohort Fondazione Policlinico Gemelli; Collection of tumor and blood samples at T0 (surgery) and T1 (6 months follow-up) Tumor microenvironment and blood multi-omics analysis In-depth functional characterization of tumor microenvironment Cancer stem cells generation and drug testing Data integration by business intelligence and development of artificial intelligence-based prognostic markers

Other: Biological biomarker analysis; Collection of tumor and blood samples at T0 (surgery) and T1 (6 months follow-up) Tumor microenvironment and blood multi-omics analysis In-depth functional characterization of tumor microenvironment Cancer stem cells generation and drug testing Data integration by business intelligence and development of AI-based prognostic markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of immune signatures in glioblastoma predictive of overall survival	Immune omic markers, namely the tumor count of the different lymphocyte subtypes and of T-cell receptor subtypes, will be correlated with overall survival.	36 months
identification of lifestyle/environmental signatures predictive of overall survival	A questionnaire investigating lifestyle/environmental patients features, including dietary habits, will be developed. Questionnaire data will be correlated with overall survival.	36 months
Cancer stem cell-based chemosensitivity assay	Assessment of the in vitro sensitivity of patient-derived cancer stem cells to chemotherapeutics	36 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: Oslo University Hospital; Istituto Superiore di Sanità; University Medical Center Goettingen; Hospital Donostia; Luxembourg Institute of Health; National Research Council
• Investigators: Principal Investigator: Quintino Giorgio D'Alessandris, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: artificial intelligence; glioblastoma; tumor microenvironment; cancer stem cell
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 5755

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