NCT06883214

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
9mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress83%
Jan 2023Jan 2027

Study Start

First participant enrolled

January 17, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2027

Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

March 12, 2025

Last Update Submit

March 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    36 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tissue samples from patients with glioma

You may qualify if:

  • histological diagnosis of glioma;
  • no concomitant primary tumor;
  • no metastatic disease;
  • availability of surgical material/tissue;
  • written informed consent.

You may not qualify if:

  • histological diagnosis of non-glial tumor;
  • patients with concomitant other solid tumors;
  • metastatic disease;
  • no surgical material/tissue available;
  • HIV seropositivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue sample

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ana Belen Diaz, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 19, 2025

Study Start

January 17, 2023

Primary Completion (Estimated)

January 17, 2027

Study Completion (Estimated)

January 17, 2027

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations