2253: Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05772741

Collaborator

Catholic University of the Sacred Heart (Other), Istituto Superiore di Sanità (Other), Heinrich-Heine University, Duesseldorf (Other)

160

Enrollment

Location

Arm

60.9

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Glioma, Malignant	Other: Biological sample collection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Grafts of Patient-derived Glioblastoma Stem Cells Onto Autologous Brain Organoids. A Precision Medicine Model for Testing Drugs Against Tumor Invasion

Actual Study Start Date :

Dec 3, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Biological sample collection Tumor tissue for glioma stem-like cell culture generation. Skin or PBMC for organoid generation	Other: Biological sample collection Collection of biological samples

Arm

Intervention/Treatment

Other: Biological sample collection

Tumor tissue for glioma stem-like cell culture generation. Skin or PBMC for organoid generation

Other: Biological sample collection

Collection of biological samples

Outcome Measures

Primary Outcome Measures

Invasion [through study completion, an average of 4 years]
Distance travelled by glioma stem cells into brain organoids
Gene assessment [through study completion, an average of 4 years]
Identification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.