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

Primary Purpose

Glioblastoma, IDH-wildtype

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biological biomarker analysis
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glioblastoma, IDH-wildtype focused on measuring glioblastoma, tumor microenvironment, cancer stem cell, artificial intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion criteria 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.

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients cohort Fondazione Policlinico Gemelli

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
Cancer stem cell-based chemosensitivity assay
Assessment of the in vitro sensitivity of patient-derived cancer stem cells to chemotherapeutics

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
July 3, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Oslo University Hospital, Istituto Superiore di Sanità, Luxembourg Institute of Health, Hospital Donostia, University Medical Center Goettingen, National Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT05941234
Brief Title
Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma
Acronym
IPerGlioGEM
Official Title
Improving Personalised Glioblastoma Care by Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Oslo University Hospital, Istituto Superiore di Sanità, Luxembourg Institute of Health, Hospital Donostia, University Medical Center Goettingen, National Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aims at: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, IDH-wildtype
Keywords
glioblastoma, tumor microenvironment, cancer stem cell, artificial intelligence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients cohort Fondazione Policlinico Gemelli
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Biological biomarker analysis
Intervention Description
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
Primary Outcome Measure Information:
Title
Identification of immune signatures in glioblastoma predictive of overall survival
Description
Immune omic markers, namely the tumor count of the different lymphocyte subtypes and of T-cell receptor subtypes, will be correlated with overall survival.
Time Frame
36 months
Title
identification of lifestyle/environmental signatures predictive of overall survival
Description
A questionnaire investigating lifestyle/environmental patients features, including dietary habits, will be developed. Questionnaire data will be correlated with overall survival.
Time Frame
36 months
Title
Cancer stem cell-based chemosensitivity assay
Description
Assessment of the in vitro sensitivity of patient-derived cancer stem cells to chemotherapeutics
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quintino Giorgio D'Alessandris, MD, PhD
Phone
+39 06 30155414
Email
quintinogiorgio.dalessandris@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Pallini, MD, PhD
Phone
+39 06 30155414
Email
roberto.pallini@unicatt.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Q. Giorgio D'Alessandris, MD
Phone
+39 06 3015 5414
Email
quintinogiorgio.dalessandris@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Liverana Lauretti, MD
Phone
+39 06 3015 5114
Email
liverana.lauretti@unicatt.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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