- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06883214
Three miRNA Signatures in Glioma: From Molecular Mechanisms to Potential Clinical Application
June 4, 2026 updated by: Regina Elena Cancer Institute
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ana Belen Diaz, Doctor
- Phone Number: +39 06-52662522
- Email: anabelen.diaz@ifo.it
Study Locations
-
-
Rome
-
Rome, Rome, Italy, 00144
- Recruiting
- "Regina Elena" National Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Tissue samples from patients with glioma
Description
Inclusion Criteria:
- histological diagnosis of glioma;
- no concomitant primary tumor;
- no metastatic disease;
- availability of surgical material/tissue;
- written informed consent.
Exclusion Criteria:
- histological diagnosis of non-glial tumor;
- patients with concomitant other solid tumors;
- metastatic disease;
- no surgical material/tissue available;
- HIV seropositivity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2023
Primary Completion (Estimated)
January 17, 2027
Study Completion (Estimated)
January 17, 2027
Study Registration Dates
First Submitted
March 12, 2025
First Submitted That Met QC Criteria
March 12, 2025
First Posted (Actual)
March 19, 2025
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 4, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RS1821/23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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