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NCT Number: NCT05941234

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

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.

Recruiting

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Key information

Conditions

Glioblastoma, IDH-wildtype Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

To be enrolled in the study patients must not:

  • 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;
  • Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2021 World Health Organization classification.

Treatment and study plan

Biological biomarker analysis

Other

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

Primary outcomes

  1. Identification of immune signatures in glioblastoma predictive of overall survival

    Time frame: 36 months

    Immune omic markers, namely the tumor count of the different lymphocyte subtypes and of T-cell receptor subtypes, will be correlated with overall survival.

  2. identification of lifestyle/environmental signatures predictive of overall survival

    Time frame: 36 months

    A questionnaire investigating lifestyle/environmental patients features, including dietary habits, will be developed. Questionnaire data will be correlated with overall survival.

  3. Cancer stem cell-based chemosensitivity assay

    Time frame: 36 months

    Assessment of the in vitro sensitivity of patient-derived cancer stem cells to chemotherapeutics

Study contacts

Contact information is provided by the study sponsor or research team.

Quintino Giorgio D'Alessandris, MD, PhD

CONTACT

[email protected]

+39 06 30155414

Roberto Pallini, MD, PhD

CONTACT

[email protected]

+39 06 30155414

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Hospital Donostia
  • Istituto Superiore di Sanità
  • Luxembourg Institute of Health
  • National Research Council
  • Oslo University Hospital
  • University Medical Center Goettingen

Registry information

Official study title

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

Acronym: IPerGlioGEM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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