GliomaNCT06883214
Three miRNA Signatures in Glioma: From Molecular Mechanisms to Potential Clinical Application
An observational study of Glioma, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Individual overexpression of the three miRNAs negatively affects cell viability and proliferation mainly in grade III IDH-wild type cells, while in higher grade cells, the effect is more pronounced when the entire signature is overexpressed, individual and combined overexpression of the signature members is able to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2023to 17 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tissue samples from patients with glioma
Who may be able to join
- histological diagnosis of glioma;
- no concomitant primary tumor;
- no metastatic disease;
- availability of surgical material/tissue;
- written informed consent.
Who cannot join
- histological diagnosis of non-glial tumor;
- patients with concomitant other solid tumors;
- metastatic disease;
- no surgical material/tissue available;
- HIV seropositivity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, Rome, 00144
About this study
Official title: Deciphering the Functional Role of a Three-miRNA Signature in Glioma: From Molecular Mechanisms to Potential Clinical Application
Individual overexpression of the three miRNAs negatively affects cell viability and proliferation mainly in grade III IDH-wild type cells, while in higher grade cells, the effect is more pronounced when the entire signature is overexpressed, individual and combined overexpression of the signature members is able to determine a significant reduction in both migration and invasion. Therefore, ectopic expression of the miRNAs identified by us has a negative impact on cell viability, proliferation and apoptosis, but above all on migration and invasion.
Read the detailed description
Decipher the impact and functional role of the signature formed by miR-1-3p, miR-26a-1-3p and miR-487b-3p on glioma biology. The functional role of the miRNAs of the signature will be assessed with gain/loss of function strategies, using primary glioma cells derived from patients with native IDH-wild type or mutated status. To set up the system we will start the study using glioma cell lines derived from patients already well characterized from a molecular and immunohistochemical point of view following the criteria reported by the new update of the 2016 WHO classification of tumors of the central nervous system. Furthermore, the involvement of the signature in the response to treatment will be evaluated. Despite the application of the most recent treatment protocols, the prognosis of patients with glioma remains unfavorable especially for patients with grade 4 glioma IDH-wild type in which resistance to radiotherapy and temozolamide contributes significantly to the negative outcome. Since it has been reported that some miRNAs can promote chemosensitization on a wide variety of tumors, including gliomas, the involvement of the miRNA signature in the response to treatment of these tumors will be studied. Cellular sensitivity to radiotherapy and temozolamide will be evaluated by dose-response curves in cell lines and primary cells derived from both IDH-wild type and IDH-mutated patients.
- Conditions
- Glioma
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-response curves
Cellular sensitivity to radiotherapy and temozolamide will be assessed by dose-response curves in both IDH-wild type and IDH-mutated patient-derived cell lines and primary cells.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start17 Jan 2023
- Primary completion17 Jan 2027 (estimated)
- Study completion17 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, San Camillo Hospital, Rome, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Neuromed IRCCS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883214
- Sponsor's protocol ID
- RS1821/23
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Functional Role of a Three-miRNA Signature in Glioma: From Molecular Mechanisms to Potential Clinical Application
- ClinicalTrials.gov ID
- NCT06883214
- Acronym / sponsor ID
- RS1821/23
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, San Camillo Hospital, Rome, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Neuromed IRCCS
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 Jan 2027 (estimated)
- Study completion
- 17 Jan 2027 (estimated)
- First posted
- 19 Mar 2025 (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.
Individual overexpression of the three miRNAs negatively affects cell viability and proliferation mainly in grade III IDH-wild type cells, while in higher grade cells, the effect is more pronounced when the entire signature is overexpressed, individual and combined overexpression of the signature members is able to determine a significant reduction in both migration and invasion. Therefore, ectopic expression of the miRNAs identified by us has a negative impact on cell viability, proliferation and apoptosis, but above all on migration and invasion.
Detailed description
Decipher the impact and functional role of the signature formed by miR-1-3p, miR-26a-1-3p and miR-487b-3p on glioma biology. The functional role of the miRNAs of the signature will be assessed with gain/loss of function strategies, using primary glioma cells derived from patients with native IDH-wild type or mutated status. To set up the system we will start the study using glioma cell lines derived from patients already well characterized from a molecular and immunohistochemical point of view following the criteria reported by the new update of the 2016 WHO classification of tumors of the central nervous system. Furthermore, the involvement of the signature in the response to treatment will be evaluated. Despite the application of the most recent treatment protocols, the prognosis of patients with glioma remains unfavorable especially for patients with grade 4 glioma IDH-wild type in which resistance to radiotherapy and temozolamide contributes significantly to the negative outcome. Since it has been reported that some miRNAs can promote chemosensitization on a wide variety of tumors, including gliomas, the involvement of the miRNA signature in the response to treatment of these tumors will be studied. Cellular sensitivity to radiotherapy and temozolamide will be evaluated by dose-response curves in cell lines and primary cells derived from both IDH-wild type and IDH-mutated patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tissue samples from patients with glioma
Key inclusion criteria (5 listed)
- histological diagnosis of glioma;
- no concomitant primary tumor;
- no metastatic disease;
- availability of surgical material/tissue;
- written informed consent.
Key exclusion criteria (5 listed)
- histological diagnosis of non-glial tumor;
- patients with concomitant other solid tumors;
- metastatic disease;
- no surgical material/tissue available;
- HIV seropositivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dose-response curves
Time frame: 36 months
Cellular sensitivity to radiotherapy and temozolamide will be assessed by dose-response curves in both IDH-wild type and IDH-mutated patient-derived cell lines and primary cells.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Regina Elena Cancer Institute 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Belen Diaz, Doctor (06-52662522 ext. +39, anabelen.diaz@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-response curves (time frame: 36 months). 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 5 Jun 2026.