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Completed

NCT Number: NCT05772767

Modulation of Ciliogenesis in Glioma Stem Cells

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To 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 been made at first surgery), according with RANO criteria (Wen, 2010);
  • Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery FPG;
  • 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 GBM, according with 2016 WHO classification.

Treatment and study plan

Biological sample collection

Other

Collection of tumor tissue and blood for stem cell culture and organoids generation.

Dissecting ciliogenesis players

Other

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.

Validating ciliogenesis players

Diagnostic Test

Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RF2019-1236878

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 16, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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