Modulation of Ciliogenesis in Glioma Stem Cells

Glioblastoma Clinical Trial

— RF2019-1236878  

Official title:

Control of Growth and Invasiveness of Glioblastoma by Modulation of Ciliogenesis in Glioma Stem Cells. A Novel Target Against Glioblastoma for Precision Medicine. RF-2019-12368786

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772767
• Other study ID #: 3782
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Roberto Pallini, MD, PhD
• Phone: +39 06 30151
• Email: roberto.pallini[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Glioma, Malignant

Intervention

Other:
• Biological sample collection
Collection of tumor tissue and blood for stem cell culture and organoids generation.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Istituto Superiore di Sanità

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological	Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.	Through study completion, an average of 2 years