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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Quintino Giorgio D'Alessandris, MD, PhD
quintinogiorgio.dalessandris@policlinicogemelli.it
+39 06 30155414
Backup
Roberto Pallini, MD, PhD
roberto.pallini@unicatt.it
+39 06 30155414
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 120
Treatments
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
Sponsors
Collaborators: National Research Council, Hospital Donostia, Oslo University Hospital, Istituto Superiore di Sanità, Luxembourg Institute of Health, University Medical Center Goettingen
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov