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Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06178692
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regina Elena Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Maria Giulia Rizzo, Doctor
Principal Investigator Affiliation IRCCS "Regina Elena" National Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Biomarker
Additional Details

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.

Arms & Interventions

Arms

: Arm 1

IDH1 mutated

: Arm 2

IDH1 wt

Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

"Regina Elena" National Cancer Institute, Rome, Italy

Status

Address

"Regina Elena" National Cancer Institute

Rome, , 00144

Nearest Location


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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