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Modulation of Ciliogenesis in Glioma Stem Cells

Study Purpose

The study aims at investigating the cilium-related transcriptome in patients-derived glioblastoma stem cells and the potential impact of modulation of cilium players in vitro, in vivo and ex vivo in glioblastoma brain organoids. Moreover, drugs inhibiting cilia disassembly will be tested. Finally, the potential prognostic role of a cilium-related gene expression signature in glioblastoma will be assessed.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & 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 been made at first surgery), according with RANO criteria (Wen, 2010); 3. Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery FPG; 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 GBM, according with 2016 WHO classification.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05772767
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Glioma, Malignant

Arms & Interventions

Arms

Other: Biological sample collection

Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.

Interventions

Other: - Biological sample collection

Collection of tumor tissue and blood for stem cell culture and organoids generation.

Other: - Dissecting ciliogenesis players

Assessment of cilium-related transcriptome in glioblastoma stem cells. Modulation of cilium-related genes and administration of cilium-targeted drugs to glioblastoma stem cells in vitro and ex vivo in glioblastoma brain organoids.

Diagnostic Test: - Validating ciliogenesis players

Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rome, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , 00168

Site Contact

Q. Giorgio D'Alessandris, MD

[email protected]

+39 06 3015 5414

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