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Recruiting NCT05941234

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

Trial Parameters

Condition Glioblastoma, IDH-wildtype
Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-02-29
Completion 2026-05-30
Interventions
Biological biomarker analysis

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.

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.

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