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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05941234
• Collaborator: Oslo University Hospital (Other), Istituto Superiore di Sanità (Other), Luxembourg Institute of Health (Other), Hospital Donostia (Other), University Medical Center Goettingen (Other), National Research Council (Other)
• Enrollment: 120
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31.9
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma, IDH-wildtype	Other: Biological biomarker analysis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Improving Personalised Glioblastoma Care by Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence Approaches
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2025
• Anticipated Study Completion Date: Apr 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Identification of immune signatures in glioblastoma predictive of overall survival [36 months]

   Immune omic markers, namely the tumor count of the different lymphocyte subtypes and of T-cell receptor subtypes, will be correlated with overall survival.

2. identification of lifestyle/environmental signatures predictive of overall survival [36 months]

   A questionnaire investigating lifestyle/environmental patients features, including dietary habits, will be developed. Questionnaire data will be correlated with overall survival.

3. Cancer stem cell-based chemosensitivity assay [36 months]

   Assessment of the in vitro sensitivity of patient-derived cancer stem cells to chemotherapeutics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome		Italy	00168

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05941234
• Other Study ID Numbers: 5755
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS: glioblastoma; tumor microenvironment; cancer stem cell; artificial intelligence
• Additional relevant MeSH terms: Glioblastoma

Study Results

No Results Posted as of Jul 12, 2023