Modulation of Ciliogenesis in Glioma Stem Cells (RF2019-1236878)

March 11, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Control of Growth and Invasiveness of Glioblastoma by Modulation of Ciliogenesis in Glioma Stem Cells. A Novel Target Against Glioblastoma for Precision Medicine. RF-2019-12368786

The study aims at investigating the cilium-related transcriptome in patients-derived glioblastoma stem cells and the potential impact of modulation of cilium players in vitro, in vivo and ex vivo in glioblastoma brain organoids. Moreover, drugs inhibiting cilia disassembly will be tested. Finally, the potential prognostic role of a cilium-related gene expression signature in glioblastoma will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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 Locations

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

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

Description

Inclusion Criteria:

To 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 been made at first surgery), according with RANO criteria (Wen, 2010);
  3. Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery FPG;
  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 GBM, 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
Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.
Other: Biological sample collection
Collection of tumor tissue and blood for stem cell culture and organoids generation.
Other: Dissecting ciliogenesis players
Assessment of cilium-related transcriptome in glioblastoma stem cells. Modulation of cilium-related genes and administration of cilium-targeted drugs to glioblastoma stem cells in vitro and ex vivo in glioblastoma brain organoids.
Diagnostic test: Validating ciliogenesis players
Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological
Time Frame: Through study completion, an average of 2 years
Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.
Through study completion, an average of 2 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

Istituto Superiore di Sanità
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Investigators

  • Principal Investigator: Roberto Pallini, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

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)

February 15, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

July 13, 2024

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 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3782

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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