Validation Study of a Serum-miRNA Signature in Glioma Patients.

NCT06178692 | Unknown

• 1 other identifier: RS1337/20
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Transfer of information in the clinical setting for diagnosis

  Enlistment period: 6-12 months Total duration of the study: 18-24 months

• Implementation of clinical trials leveraging know-how.

  Enlistment period: 6-12 months Total duration of the study: 18-24 months

Study Arms (2)

Arm 1

IDH1 mutated

Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 status

Arm 2

IDH1 wt

Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 status

Interventions

Validation of miRNA-serum signatures associated with IDH1 status DIAGNOSTIC_TEST

Validation of miRNA-serum signatures associated with IDH1 status and prognosis, as reliable, specific and sensitive circulating diagnostic biomarkers also useful to improve prognostic stratification of patients.

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• histological diagnosis of glioma;
• age≥18 years;
• No other primary tumor;
• No metastatic disease
• Informed consent on treatment and molecular analysis

You may not qualify if:

• Histological diagnosis of non-glial tumor;
• age\< 18;
• patients with concomitant other solid tumors
• metastatic disease; HIV seropositivity.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Azienda Ospedaliero Universitaria di Sassari: collaborator
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• University of Roma La Sapienza: collaborator
• Plymouth State University: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples: two test tubes (6ml each) with activator of peripheral blood coagulation at diagnosis, at discharge after surgery (4-6 days after surgery) and/or at the first post-surgery check-up. From the serum obtained from blood samples will subsequently be extracted the RNA and the expression level of the miRNAs will be analyzed in individual samples by digital PCR. * Tissue samples: where possible, biopsy tissue taken for diagnostic purposes and fixed in formalin and embedded in paraffin (FFPE) will be analyzed for the expression of miRNAs of interest by Real-Time PCR.

Study Officials

• Maria Giulia Rizzo, Doctor

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: December 21, 2023
• Study Start: May 10, 2020
• Primary Completion: November 17, 2022
• Study Completion: May 10, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

IT (1)