Modulation of Ciliogenesis in Glioma Stem Cells

Not Applicable

Recruiting

• Conditions: Glioblastoma; Glioma, Malignant
• Interventions: Other: Biological sample collection; Other: Dissecting ciliogenesis players; Diagnostic Test: Validating ciliogenesis players

• Registration Number: NCT05772767
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-02-15
• Status Verified: 2023-02
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological sample collection	Biological sample collection	Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.
Biological sample collection	Dissecting ciliogenesis players	Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.
Biological sample collection	Validating ciliogenesis players	Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids.

Primary Outcome Measures

Name	Time	Method
Biological	Through study completion, an average of 2 years	Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy