Back to resultsGrafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs (2253)
Primary Purpose
Glioblastoma, Glioma, Malignant
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biological sample collection
Sponsored by
About this trial
This is an interventional basic science trial for Glioblastoma focused on measuring glioma stem-like cells, brain organoids, brain invasion, ciliogenesis
Eligibility Criteria
Inclusion Criteria: o 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 made at first surgery), according with RANO criteria (Wen, 2010); Be a candidate to neurosurgery for glioblastoma; 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 glioblastoma, 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
Tumor tissue for glioma stem-like cell culture generation. Skin or PBMC for organoid generation
Outcomes
Primary Outcome Measures
Invasion
Distance travelled by glioma stem cells into brain organoids
Gene assessment
Identification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis
Secondary Outcome Measures
Full Information
NCT ID
NCT05772741
First Posted
February 23, 2023
Last Updated
March 6, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Catholic University of the Sacred Heart, Istituto Superiore di Sanità, Heinrich-Heine University, Duesseldorf
1. Study Identification
Unique Protocol Identification Number
NCT05772741
Brief Title
Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs
Acronym
2253
Official Title
Grafts of Patient-derived Glioblastoma Stem Cells Onto Autologous Brain Organoids. A Precision Medicine Model for Testing Drugs Against Tumor Invasion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Catholic University of the Sacred Heart, Istituto Superiore di Sanità, Heinrich-Heine University, Duesseldorf
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioma, Malignant
Keywords
glioma stem-like cells, brain organoids, brain invasion, ciliogenesis
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
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological sample collection
Arm Type
Other
Arm Description
Tumor tissue for glioma stem-like cell culture generation. Skin or PBMC for organoid generation
Intervention Type
Other
Intervention Name(s)
Biological sample collection
Intervention Description
Collection of biological samples
Primary Outcome Measure Information:
Title
Invasion
Description
Distance travelled by glioma stem cells into brain organoids
Time Frame
through study completion, an average of 4 years
Title
Gene assessment
Description
Identification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis
Time Frame
through study completion, an average of 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
o 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 made at first surgery), according with RANO criteria (Wen, 2010);
Be a candidate to neurosurgery for glioblastoma;
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 glioblastoma, 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 3015 5414
Email
roberto.pallini@unicatt.it
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Ricci-Vitiani, PhD
Phone
+39 06 49901
Email
lucia.riccivitiani@iss.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
Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs
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