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Trial Title:
Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma
NCT ID:
NCT05941234
Condition:
Glioblastoma, IDH-wildtype
Conditions: Official terms:
Glioblastoma
Conditions: Keywords:
glioblastoma
tumor microenvironment
cancer stem cell
artificial intelligence
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Biological biomarker analysis
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
Arm group label:
Patients cohort Fondazione Policlinico Gemelli
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario A. Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Contact:
Last name:
Q. Giorgio D'Alessandris, MD
Phone:
+39 06 3015 5414
Email:
quintinogiorgio.dalessandris@policlinicogemelli.it
Contact backup:
Last name:
Liverana Lauretti, MD
Phone:
+39 06 3015 5114
Email:
liverana.lauretti@unicatt.it
Start date:
September 1, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
Istituto Superiore di SanitÃ
Agency class:
Other
Collaborator:
Agency:
Luxembourg Institute of Health
Agency class:
Other
Collaborator:
Agency:
Hospital Donostia
Agency class:
Other
Collaborator:
Agency:
University Medical Center Goettingen
Agency class:
Other
Collaborator:
Agency:
National Research Council
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05941234
