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

NCT05941234 | Recruiting

• 1 other identifier: 5755
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at:

1. 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. 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. 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.

Conditions

Glioblastoma, IDH-wildtype

Keywords

glioblastoma; tumor microenvironment; cancer stem cell; artificial intelligence

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients cohort Fondazione Policlinico Gemelli

OTHER

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

Interventions

Biological biomarker analysis OTHER

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

Patients cohort Fondazione Policlinico Gemelli

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be enrolled in the study patients must:
• Have a radiological diagnosis of supratentorial glioblastoma, or
• 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;
• Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery Fondazione Policlinico Gemelli IRCCS;
• Be of an age of 18 years or above;
• Provide written informed consent for participation to the study.

You may not qualify if:

• To be enrolled in the study patients must not:
• 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;
• Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2021 World Health Organization classification.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Oslo University Hospital: collaborator
• Istituto Superiore di Sanità: collaborator
• Luxembourg Institute of Health: collaborator
• Hospital Donostia: collaborator
• University Medical Center Goettingen: collaborator
• National Research Council: collaborator

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Quintino Giorgio D'Alessandris, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 12, 2023
• Study Start: February 29, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)