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

Glioblastoma Clinical Trial

— 2253  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772741
• Other study ID #: 2253
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Roberto Pallini, MD, PhD
• Phone: +39 06 3015 5414
• Email: roberto.pallini[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Glioma, Malignant

Intervention

Other:
• Biological sample collection
Collection of biological samples

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (4)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Catholic University of the Sacred Heart, Heinrich-Heine University, Duesseldorf, Istituto Superiore di Sanità

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasion	Distance travelled by glioma stem cells into brain organoids	through study completion, an average of 4 years
Primary	Gene assessment	Identification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis	through study completion, an average of 4 years