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

NCT05772741 | Unknown

• 1 other identifier: 2253
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Glioma, Malignant

Keywords

glioma stem-like cells; brain organoids; brain invasion; ciliogenesis

Outcome Measures

Primary Outcomes (2)

• Invasion

  Distance travelled by glioma stem cells into brain organoids

  through study completion, an average of 4 years

• 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

Study Arms (1)

Biological sample collection

OTHER

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

Other: Biological sample collection

Interventions

Biological sample collection OTHER

Collection of biological samples

Biological sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Catholic University of the Sacred Heart: collaborator
• Istituto Superiore di Sanità: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Roberto Pallini, MD, PhD

CONTACT

+39 06 3015 5414; roberto.pallini@unicatt.it

Lucia Ricci-Vitiani, PhD

CONTACT

+39 06 49901; lucia.riccivitiani@iss.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 16, 2023
• Study Start: December 3, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)