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Trial Title:
Modulation of Ciliogenesis in Glioma Stem Cells
NCT ID:
NCT05772767
Condition:
Glioblastoma
Glioma, Malignant
Conditions: Official terms:
Glioblastoma
Glioma
Conditions: Keywords:
cilia disassembly complex
Nek2
glioblastoma stem cells
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Biological sample collection
Description:
Collection of tumor tissue and blood for stem cell culture and organoids generation.
Arm group label:
Biological sample collection
Intervention type:
Other
Intervention name:
Dissecting ciliogenesis players
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.
Arm group label:
Biological sample collection
Intervention type:
Diagnostic Test
Intervention name:
Validating ciliogenesis players
Description:
Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.
Arm group label:
Biological sample collection
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.
Criteria for 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario A. Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Q. Giorgio D'Alessandris, MD
Phone:
+39 06 3015 5414
Email:
quintinogiorgio.dalessandris@policlinicogemelli.it
Start date:
February 15, 2021
Completion date:
February 28, 2024
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
Istituto Superiore di SanitÃ
Agency class:
Other
Collaborator:
Agency:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05772767
