BiomarkerNCT06178692
Validation Study of a Serum-miRNA Signature in Glioma Patients.
An observational study of Biomarker, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomarker
- What is being tested?
- Validation of miRNA-serum signatures associated with IDH1 status
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2020to 10 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- histological diagnosis of glioma;
- age≥18 years;
- No other primary tumor;
- No metastatic disease
- Informed consent on treatment and molecular analysis
Who cannot join
- Histological diagnosis of non-glial tumor;
- age< 18;
- patients with concomitant other solid tumors
- metastatic disease; HIV seropositivity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of a Serum-miRNA Signature, Associated With IDH1 Stuatus, as Non-invasive Diagnostic and Prognostic Biomarkers in Glioma Patients
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.
Read the 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.
- Conditions
- Biomarker
- Being tested
- Validation of miRNA-serum signatures associated with IDH1 status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of miRNA-serum signatures associated with IDH1 statusDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | IDH1 mutated Receives: Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 status | |
| Arm 2 | IDH1 wt Receives: Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Enlistment period: 6-12 months Total duration of the study: 18-24 months
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.
Measured: Enlistment period: 6-12 months Total duration of the study: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start10 May 2020
- Primary completion17 Nov 2022
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Sassari, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, University of Roma La Sapienza, Plymouth State University
- Responsible party
- Sponsor
- Investigators
- Maria Giulia Rizzo, Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178692
- Sponsor's protocol ID
- RS1337/20
- Status last verified
- Dec 2023
- First submitted
- 28 Mar 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of a Serum-miRNA Signature, Associated With IDH1 Stuatus, as Non-invasive Diagnostic and Prognostic Biomarkers in Glioma Patients
- ClinicalTrials.gov ID
- NCT06178692
- Acronym / sponsor ID
- RS1337/20
- Conditions
- Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Sassari, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, University of Roma La Sapienza, Plymouth State University
- Study start
- 10 May 2020 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 statusIDH1 mutated |
| Arm 2 | – | Diagnostic Test: Validation of miRNA-serum signatures associated with IDH1 statusIDH1 wt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- histological diagnosis of glioma;
- age≥18 years;
- No other primary tumor;
- No metastatic disease
- Informed consent on treatment and molecular analysis
Key exclusion criteria (4 listed)
- Histological diagnosis of non-glial tumor;
- age< 18;
- patients with concomitant other solid tumors
- metastatic disease; HIV seropositivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of miRNA-serum signatures associated with IDH1 statusValidation 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. | Diagnostic test | Arm 1, Arm 2 |
Primary outcome
Identification of specific forms of circulating microRNAs invasive brain tumors
Time frame: Enlistment period: 6-12 months Total duration of the study: 18-24 months
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.
2 secondary outcomes
Transfer of information in the clinical setting for diagnosis
Time frame: Enlistment period: 6-12 months Total duration of the study: 18-24 months
Implementation of clinical trials leveraging know-how.
Time frame: Enlistment period: 6-12 months Total duration of the study: 18-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Giulia Rizzo, Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarker, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of specific forms of circulating microRNAs invasive brain tumors (time frame: Enlistment period: 6-12 months Total duration of the study: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.