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Trial Title:
Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs
NCT ID:
NCT05772741
Condition:
Glioblastoma
Glioma, Malignant
Conditions: Official terms:
Glioblastoma
Glioma
Conditions: Keywords:
glioma stem-like cells
brain organoids
brain invasion
ciliogenesis
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 biological samples
Arm group label:
Biological sample collection
Summary:
In patients operated for glioblastoma, glioma stem-like cell lines will be obtained from
tumor tissue, and IPSCs from skin fibroblasts or PBMCs. Brain organoids will be generated
from IPSCs and co-cultured with IPSCs to study brain invasion and ciliogenesis. 3D genome
architecture of glioma stem-like cells will be investigated. Gene modulation and
pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
o 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 (Wen, 2010);
3. Be a candidate to neurosurgery for glioblastoma;
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 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:
December 3, 2018
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
Catholic University of the Sacred Heart
Agency class:
Other
Collaborator:
Agency:
Istituto Superiore di SanitÃ
Agency class:
Other
Collaborator:
Agency:
Heinrich-Heine University, Duesseldorf
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/NCT05772741
