Back to resultsModulation of Ciliogenesis in Glioma Stem Cells (RF2019-1236878)
Primary Purpose
Glioblastoma, Glioma, Malignant
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biological sample collection
Dissecting ciliogenesis players
Validating ciliogenesis players
Sponsored by
About this trial
This is an interventional basic science trial for Glioblastoma focused on measuring cilia disassembly complex, Nek2, glioblastoma stem cells
Eligibility Criteria
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 been made at first surgery), according with RANO criteria (Wen, 2010); Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery FPG; 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 GBM, according with 2016 WHO classification.
Sites / Locations
- Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Biological sample collection
Arm Description
Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.
Outcomes
Primary Outcome Measures
Biological
Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.
Secondary Outcome Measures
Full Information
NCT ID
NCT05772767
First Posted
February 23, 2023
Last Updated
March 6, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Istituto Superiore di Sanità, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05772767
Brief Title
Modulation of Ciliogenesis in Glioma Stem Cells
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Istituto Superiore di Sanità, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioma, Malignant
Keywords
cilia disassembly complex, Nek2, glioblastoma stem cells
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological sample collection
Arm Type
Other
Arm Description
Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.
Intervention Type
Other
Intervention Name(s)
Biological sample collection
Intervention Description
Collection of tumor tissue and blood for stem cell culture and organoids generation.
Intervention Type
Other
Intervention Name(s)
Dissecting ciliogenesis players
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Validating ciliogenesis players
Intervention Description
Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.
Primary Outcome Measure Information:
Title
Biological
Description
Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 been made at first surgery), according with RANO criteria (Wen, 2010);
Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery FPG;
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 GBM, according with 2016 WHO classification.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Pallini, MD, PhD
Phone
+39 06 30151
Email
roberto.pallini@unicatt.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Olivi, MD
Phone
+39 06 3015 4120
Email
alessandro.olivi@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Q. Giorgio D'Alessandris, MD
Phone
+39 06 3015 5414
Email
quintinogiorgio.dalessandris@policlinicogemelli.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modulation of Ciliogenesis in Glioma Stem Cells
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