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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Glioblastoma, IDH-wildtype

Treatments

Other: Biological biomarker analysis

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Patients cohort Fondazione Policlinico Gemelli
Other group
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 artificial intelligence-based prognostic markers
Treatment:
Other: Biological biomarker analysis

Trial contacts and locations

1

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Central trial contact

Quintino Giorgio D'Alessandris, MD, PhD; Roberto Pallini, MD, PhD

Data sourced from clinicaltrials.gov

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