GlioblastomaRF2019-1236878NCT05772767
Modulation of Ciliogenesis in Glioma Stem Cells
A study testing Biological sample collection, Dissecting ciliogenesis players and Validating ciliogenesis players in people with Glioblastoma and Glioma, Malignant, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioma, Malignant
- What is being tested?
- Biological sample collection, Dissecting ciliogenesis players and Validating ciliogenesis players
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2021to 13 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Glioblastoma, Glioma, Malignant
- Being tested
- Biological sample collection, Dissecting ciliogenesis players, Validating ciliogenesis players
- Keywords
- cilia disassembly complex, Nek2, glioblastoma stem cells
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
Collection of tumor tissue and blood for stem cell culture and organoids generation.
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.
Validating ciliogenesis playersDiagnostic test
Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.
| Study group | Role | What they receive |
|---|---|---|
| Biological sample collection | Other | Collection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids. Receives: Other: Biological sample collection; Other: Dissecting ciliogenesis players; Diagnostic Test: Validating ciliogenesis players |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological
Correlation between modulation of cilia disassembly complex genes, and tumor growth and invasion in brain organoids.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start15 Feb 2021
- Primary completion31 Dec 2023
- Study completion13 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Superiore di Sanità, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Responsible party
- Sponsor
- Investigators
- Roberto Pallini, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772767
- Sponsor's protocol ID
- 3782
- Acronym
- RF2019-1236878
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05772767
- Acronym / sponsor ID
- RF2019-1236878 / 3782
- Conditions
- Glioblastoma, Glioma, Malignant
- Keywords
- cilia disassembly complex, Nek2, glioblastoma stem cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Istituto Superiore di Sanità, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological sample collection | Other | Other: Biological sample collection, Other: Dissecting ciliogenesis players, Diagnostic Test: Validating ciliogenesis playersCollection of tumor tissue and PBMC for the generation of glioblastoma stem cell cultures and brain organoids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionCollection of tumor tissue and blood for stem cell culture and organoids generation. | Other | Biological sample collection |
| Dissecting ciliogenesis playersAssessment 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. | Other | Biological sample collection |
| Validating ciliogenesis playersCilium-related signature will be studied in tumor tissue to evaluate its prognostic role. | Diagnostic test | Biological sample collection |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Pallini, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample collection, Dissecting ciliogenesis players and Validating ciliogenesis players in people with Glioblastoma and Glioma, Malignant, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.