NCT05941234 Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma
| NCT ID | NCT05941234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Glioblastoma, IDH-wildtype |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-29 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-02-29 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Quintino Giorgio D'Alessandris, MD, PhD
✉ quintinogiorgio.dalessandris@policlinicogemelli.it📞 +39 06 30155414
Quintino Giorgio D'Alessandris, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05941234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma, IDH-wildtype. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05941234 currently recruiting?
Yes, NCT05941234 is actively recruiting participants. Contact the research team at quintinogiorgio.dalessandris@policlinicogemelli.it for enrollment information.
Where is the NCT05941234 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05941234 clinical trial?
NCT05941234 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Quintino Giorgio D'Alessandris, MD, PhD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 120 participants.
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