Clinical trial NCT06178692: Validation Study of a Serum-miRNA Signature in Glioma Patients.
Official title: Validation Study of a Serum-miRNA Signature, Associated With IDH1 Stuatus, as Non-invasive Diagnostic and Prognostic Biomarkers in Glioma Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Biomarker
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria di Sassari
name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: University of Roma La Sapienza
name: Plymouth State University
First posted: 2023-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Scientific data suggest that a serum signature of miRNA could be a promising noninvasive diagnostic and prognostic tool for stratify, by liquid biopsy, patients with glioma according to IDH1 status. It has the primary objective of validating, through non-invasive methods, a signature of Serum miRNAs as reliable, specific and sensitive diagnostic and/or prognostic biomarkers for patients affected by glioma which can also help integrate the molecular analyzes performed on biopsies tissue. The ultimate goal is therefore to validate specific biomarkers for a "medicine" approach personalized" for glioma patients, with potential clinical benefits resulting from improved patient management and identification of the best possible therapy for specific subgroups biological data of patients. Blood samples from cancer patients will be used brain with different IDH1 status and of different grade, recruited from the centers participating in the study.

Where possible, tissue samples coming, according to clinical practice, from biopsy will be used to the diagnosis of the same patient.

For the analyzes foreseen by the study it will be necessary to take 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.

The method of collection of peripheral blood samples at diagnosis, discharge and/or following the first post-surgery check-up it will be kept uniform throughout study, to minimize preanalytical variables. Any hemolyzed samples will be identified, and excluded from the study, through spectrophotometric analysis and/or by analyzing the level of expression of miR-451, abundant in erythrocytes, and miR-23a, not affected by hemolysis.

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.

Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: Transfer of information in the clinical setting for diagnosis
timeFrame: Enlistment period: 6-12 months Total duration of the study: 18-24 months
measure: Implementation of clinical trials leveraging know-how.
timeFrame: Enlistment period: 6-12 months Total duration of the study: 18-24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Maria Giulia Rizzo, Doctor
role: PRINCIPAL_INVESTIGATOR
References: