GliomaNCT03865355
Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients
An observational study of Glioma and Glioblastoma Multiforme, run by Novosibirsk State University at 1 site in Russia.
Trial summary
This is an exploratory, non-interventional and translational clinical study. The aim of this study is to analyze blood and cerebrospinal fluid metabolomic profile in glioma patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma, Glioblastoma Multiforme
- What is being tested?
- Non- interventional
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 13 Mar 2019to 11 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with suspected newly diagnosed glioma with planned surgical intervention will be eligible.
Who may be able to join
- All patients with suspected newly diagnosed glioma (grade I, II, III or glioblastoma) with planned surgical intervention (resection or biopsy).
- Patient aged 18 years or older
- Patients have to be able to give informed consent
Who cannot join
- Prior Radiotherapy to the central nervous system
- Prior Chemotherapy within the last 5 years
- Any prior central nervous system malignancy
- Any surgery during last 6 month
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk State University
Novosibirsk, Novosibirsk Oblast, 630090
About this study
Official title: Unique Blood and CSF Metabolic Profile Association With Gliomas in Adults
This is an exploratory, non-interventional and translational clinical study. The aim of this study is to analyze blood and cerebrospinal fluid metabolomic profile in glioma patients.
Read the detailed description
The analysis of metabolic profile in the plasma and CSF could become the new less invasive approach in the establishing diagnosis as well as an important prognostic factor in patients with glioma. The researches will assess the blood and CSF metabolic profile in patients with different types of gliomas as well as in patient without ones. This can help to find new biomarkers for low- and high-grade gliomas correlating with patient outcomes.
Blood and CSF samples will be collected from patients with suspected newly diagnosed low-grade (I-II) or high-grade (III-IV) gliomas as well as from patients who have hospitalized for reconstructive surgery after craniofacial trauma. All samples will be collected before any surgical intervention and at various follow-up time points until progression or death. The results of the study are planned to be translated into the hospital setting as support to other diagnostics procedures and to the differential diagnosis between glioma grades.
- Conditions
- Glioma, Glioblastoma Multiforme
- Being tested
- Non- interventional
- Keywords
- Metabolomic profile, Biomarkers
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non- interventionalOther
Translational, observational study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 / High grade Glioma | Cohort 1:
1. Histologically confirmed high-grade glioma (grade III and grade IV (glioblastoma (GBM)))
2. Planned treatment (surgery followed by radiation therapy (RT) alone or Chemotherapy alone or a combination of RT/Chemotherapy) Receives: Other: Non- interventional | |
| Cohort 2 / Low grade Glioma | Cohort 2:
1. Histologically confirmed low-grade (grade I/II) glioma
2. Planned treatment either expectant monitoring or surgery followed by RT alone or Chemotherapy alone or a combination of RT/Chemotherapy Receives: Other: Non- interventional | |
| Cohort 3 / Conditionally healthy volunteers | Cohort 3:
1. No oncological disease was diagnosed
2. Planned treatment (reconstructive surgery after craniofacial trauma) Receives: Other: Non- interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic phenotype of glioma patients
Plasma and CSF aminoacids, acylcarnitines, and other metabolites in glioma patients compared to conditionally healthy volunteers by high-performance liquid chromatography coupled with tandem mass spectrometry.
Measured: 5 years
Secondary outcomes (2)
Overall survival (OS)
Time between date of diagnosis and date of death
Measured: 5 years
Progression free survival (PFS)
Time between date of diagnosis and date of disease progression
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start13 Mar 2019
- Primary completion11 Apr 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novosibirsk State University
- Sponsor type
- University, hospital or other
- Collaborators
- FSBI "Federal Neurosurgical Center" Novosibirsk, Russia, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865355
- Sponsor's protocol ID
- MetGlio/19
- Status last verified
- Nov 2024
- First submitted
- 26 Feb 2019
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unique Blood and CSF Metabolic Profile Association With Gliomas in Adults
- ClinicalTrials.gov ID
- NCT03865355
- Acronym / sponsor ID
- MetGlio/19
- Conditions
- Glioma, Glioblastoma Multiforme
- Keywords
- Metabolomic profile, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novosibirsk State UniversityUniversity, hospital or other
- Collaborators
- FSBI "Federal Neurosurgical Center" Novosibirsk, Russia, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 6 Mar 2019 (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.
This is an exploratory, non-interventional and translational clinical study. The aim of this study is to analyze blood and cerebrospinal fluid metabolomic profile in glioma patients.
Detailed description
The analysis of metabolic profile in the plasma and CSF could become the new less invasive approach in the establishing diagnosis as well as an important prognostic factor in patients with glioma. The researches will assess the blood and CSF metabolic profile in patients with different types of gliomas as well as in patient without ones. This can help to find new biomarkers for low- and high-grade gliomas correlating with patient outcomes.
Blood and CSF samples will be collected from patients with suspected newly diagnosed low-grade (I-II) or high-grade (III-IV) gliomas as well as from patients who have hospitalized for reconstructive surgery after craniofacial trauma. All samples will be collected before any surgical intervention and at various follow-up time points until progression or death. The results of the study are planned to be translated into the hospital setting as support to other diagnostics procedures and to the differential diagnosis between glioma grades.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 / High grade Glioma | – | Other: Non- interventionalCohort 1: 1. Histologically confirmed high-grade glioma (grade III and grade IV (glioblastoma (GBM))) 2. Planned treatment (surgery followed by radiation therapy (RT) alone or Chemotherapy alone or a combination of RT/Chemotherapy) |
| Cohort 2 / Low grade Glioma | – | Other: Non- interventionalCohort 2: 1. Histologically confirmed low-grade (grade I/II) glioma 2. Planned treatment either expectant monitoring or surgery followed by RT alone or Chemotherapy alone or a combination of RT/Chemotherapy |
| Cohort 3 / Conditionally healthy volunteers | – | Other: Non- interventionalCohort 3: 1. No oncological disease was diagnosed 2. Planned treatment (reconstructive surgery after craniofacial trauma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected newly diagnosed glioma with planned surgical intervention will be eligible.
Key inclusion criteria (3 listed)
- All patients with suspected newly diagnosed glioma (grade I, II, III or glioblastoma) with planned surgical intervention (resection or biopsy).
- Patient aged 18 years or older
- Patients have to be able to give informed consent
Key exclusion criteria (4 listed)
- Prior Radiotherapy to the central nervous system
- Prior Chemotherapy within the last 5 years
- Any prior central nervous system malignancy
- Any surgery during last 6 month
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 |
|---|---|---|
| Non- interventionalTranslational, observational study | Other | Cohort 1 / High grade Glioma, Cohort 2 / Low grade Glioma, Cohort 3 / Conditionally healthy volunteers |
Primary outcome
Metabolic phenotype of glioma patients
Time frame: 5 years
Plasma and CSF aminoacids, acylcarnitines, and other metabolites in glioma patients compared to conditionally healthy volunteers by high-performance liquid chromatography coupled with tandem mass spectrometry.
2 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Progression free survival (PFS)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Related trials for Glioma
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glioma and Glioblastoma Multiforme, run by Novosibirsk State University at 1 site in Russia.
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 3 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: finished, as of the sponsor's last update on 14 Nov 2024. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metabolic phenotype of glioma patients (time frame: 5 years). 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 14 Nov 2024.