Biomarker Clinical Trial
Official title:
Validation Study of a Serum-miRNA Signature, Associated With IDH1 Stuatus, as Non-invasive Diagnostic and Prognostic Biomarkers in Glioma Patients
Verified date | December 2023 |
Source | Regina Elena Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | May 10, 2024 |
Est. primary completion date | November 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | "Regina Elena" National Cancer Institute | Rome |
Lead Sponsor | Collaborator |
---|---|
Regina Elena Cancer Institute | Azienda Ospedaliero Universitaria di Sassari, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Plymouth State University, University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of specific forms of circulating microRNAs invasive brain tumors | 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. |
Enlistment period: 6-12 months Total duration of the study: 18-24 months | |
Secondary | Transfer of information in the clinical setting for diagnosis | Transfer of this information into the clinical setting for diagnosis, prognosis and purposes therapeutic.
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. |
Enlistment period: 6-12 months Total duration of the study: 18-24 months | |
Secondary | Implementation of clinical trials leveraging know-how. | Implementation and interpretation of clinical trials using specific know-how generated by the collaborative effort of study participants.
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. |
Enlistment period: 6-12 months Total duration of the study: 18-24 months |
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