Analyzing stem cells and using AI to improve glioblastoma treatment

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

This study is testing how stem cells and artificial intelligence can help improve treatment for people with glioblastoma by finding ways to predict their outcomes and making sure patients have the information they need to make informed choices.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Rome)
• Trial ID: NCT05941234 on ClinicalTrials.gov

What this trial studies

This study focuses on glioblastoma, specifically IDH-wildtype, by integrating multi-omics approaches with clinical data to identify immune markers that can predict patient prognosis. It aims to enhance understanding of glioblastoma through the study of stem cell cultures and their sensitivity to various chemotherapeutics. Additionally, the study seeks to establish ethical guidelines for the use of patient data in AI-assisted prediction systems, while also creating accessible information for patients to empower them in their treatment decisions.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a radiological diagnosis of supratentorial glioblastoma or its first recurrence.

Not a fit: Patients who do not have sufficient pathological material available for analysis or lack a definitive pathological diagnosis of glioblastoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies that significantly improve the quality of life for glioblastoma patients.

How similar studies have performed: Other studies have shown promise in using multi-omics and AI approaches in cancer treatment, suggesting potential success for this novel integration in glioblastoma.

Eligibility criteria

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.

Where this trial is running

Rome

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (RECRUITING)

Study contacts

• Principal investigator: Quintino Giorgio D'Alessandris, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Quintino Giorgio D'Alessandris, MD, PhD

Conditions: Glioblastoma, IDH-wildtype, glioblastoma, tumor microenvironment, cancer stem cell, artificial intelligence