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

March 6, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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