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

Glioblastoma, IDH-wildtype Clinical Trial

— IPerGlioGEM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941234
• Other study ID #: 5755
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: June 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Quintino Giorgio D'Alessandris, MD, PhD
• Phone: +39 06 30155414
• Email: quintinogiorgio.dalessandris[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma, IDH-wildtype

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (7)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Hospital Donostia, Istituto Superiore di Sanità, Luxembourg Institute of Health, National Research Council, Oslo University Hospital, University Medical Center Goettingen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cancer stem cell-based chemosensitivity assay	Assessment of the in vitro sensitivity of patient-derived cancer stem cells to chemotherapeutics	36 months