NCT05772767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2024

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

February 23, 2023

Last Update Submit

March 11, 2025

Conditions

GlioblastomaGlioma, Malignant

Keywords

cilia disassembly complexNek2glioblastoma stem cells

Outcome Measures

Primary Outcomes (1)

  • Biological

    Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.

    Through study completion, an average of 2 years

Study Arms (1)

Biological sample collection

OTHER

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

Other: Biological sample collectionOther: Dissecting ciliogenesis playersDiagnostic Test: Validating ciliogenesis players

Interventions

Biological sample collectionOTHER

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

Biological sample collection
Dissecting ciliogenesis playersOTHER

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.

Biological sample collection
Validating ciliogenesis playersDIAGNOSTIC_TEST

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

Biological sample collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

GlioblastomaGlioma

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Roberto Pallini, MD, PhD

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 16, 2023

Study Start

February 15, 2021

Primary Completion

December 31, 2023

Study Completion

July 13, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)