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NCT05941234Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
14 Jun 2023
Start date
29 Feb 2024
Primary completion date
30 May 2026
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diseases
Glioblastoma
NCT number
NCT05941234

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 29 Feb 2024 to the primary completion date, 30 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other

  • To be enrolled in the study patients must not:
  • Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2021 World Health Organization classification.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.