Modulation of Ciliogenesis in Glioma Stem Cells

NCT ID: NCT05772767

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2024-07-13

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma Glioma, Malignant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Biological sample collection

Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.

Group Type OTHER

Biological sample collection

Intervention Type OTHER

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

Dissecting ciliogenesis players

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Biological sample collection

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

Intervention Type 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.

Intervention Type OTHER

Validating ciliogenesis players

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Superiore di Sanità

OTHER

Sponsor Role collaborator

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

OTHER_GOV

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto Pallini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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3782

Identifier Type: -

Identifier Source: org_study_id

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