Clinical trial · Observational
Validation Study of a Serum-miRNA Signature in Glioma Patients.
Validation Study of a Serum-miRNA Signature, Associated With IDH1 Stuatus, as Non-invasive Diagnostic and Prognostic Biomarkers in Glioma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, multicenter, noninterventional, nonprofit study of a cohort of patients with glioma, aimed at validating miRNA-serum signatures associated with IDH1 status and prognosis, as reliable, specific and sensitive circulating diagnostic biomarkers also useful for improve prognostic stratification of patients. The study will be conducted on serum samples at diagnosis, at 4-6 days postoperatively and/or at the first post-surgery follow-up, in a new cohort of glioma patients and representative of different IDH1 mutational statuses. Furthermore, because comparison of miRNA expression profiles in serum and tissue may provide further evidence to support the use of serum miRNAs as reliable biomarkers reliable, their expression will also be analyzed, where possible, in tissue biopsies from the same patient and compared with the expression profiles of serum miRNAs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarker | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Validation of miRNA-serum signatures associated with IDH1 status | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm 1
- description
- IDH1 mutated
- interventionNames
- Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 status
- label
- Arm 2
- description
- IDH1 wt
- interventionNames
- Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 status
Primary outcomes (1)
- measure
- Identification of specific forms of circulating microRNAs invasive brain tumors
- timeFrame
- Enlistment period: 6-12 months Total duration of the study: 18-24 months
- description
- Identification of specific circulating microRNA signatures as non-diagnostic biomarkers invasive brain tumors. The variables of interest will be summarized by descriptive statistics. ROC curve analysis will be used to evaluate the diagnostic accuracy of miRNAs to be validated. Survival analysis (Overall Survival=OS and Progression Free Survival=PFS) will be conducted through the use of the Kaplan-Meier model and risk regression models Cox proportionals. The log-rank test will be used to test for any differences between groups. The Hazard Risk (HR) and related 95% confidence intervals (95%CI) will be estimated for each variable using univariate and multivariate Cox models. A p value \<0.05 will be considered statistically significant. All analyzes will be conducted with SPSS v.21.0 software.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histological diagnosis of glioma; * age≥18 years; * No other primary tumor; * No metastatic disease * Informed consent on treatment and molecular analysis Exclusion Criteria: * Histological diagnosis of non-glial tumor; * age\< 18; * patients with concomitant other solid tumors * metastatic disease; HIV seropositivity.
References
Publications (0)
Data not yet available