CClinicalTrials.gg
CompletedNCT03865355Updated Nov 14, 2024

Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

An observational study in Glioma and Glioblastoma Multiforme, sponsored by Novosibirsk State University. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by Novosibirsk State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Glioma
  • Glioblastoma Multiforme

Keywords

  • Metabolomic profile
  • Biomarkers
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 188 observational studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Novosibirsk State University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All patients with suspected newly diagnosed glioma with planned surgical intervention will be eligible.

Inclusion criteria

  1. All patients with suspected newly diagnosed glioma (grade I, II, III or glioblastoma) with planned surgical intervention (resection or biopsy).
  2. Patient aged 18 years or older
  3. Patients have to be able to give informed consent

Exclusion criteria

Exclusion Criteria:

  1. Prior Radiotherapy to the central nervous system
  2. Prior Chemotherapy within the last 5 years
  3. Any prior central nervous system malignancy
  4. Any surgery during last 6 month
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

    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

    Other: Non- interventional

  • Cohort 3 / Conditionally healthy volunteers

    Cohort 3: 1. No oncological disease was diagnosed 2. Planned treatment (reconstructive surgery after craniofacial trauma)

    Other: Non- interventional

Interventions

  • OtherNon- interventional

    Translational, observational study

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

Secondary outcomes

  1. Overall survival (OS)

    Time between date of diagnosis and date of death

    Time frame: 5 years

  2. Progression free survival (PFS)

    Time between date of diagnosis and date of disease progression

    Time frame: 5 years

07

Study locations

1 site
  • Novosibirsk State University
    Novosibirsk, Novosibirskaya Oblast' 630090, Russian Federation
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03865355
Lead sponsor
Novosibirsk State University
Collaborators
FSBI "Federal Neurosurgical Center" Novosibirsk, Russia, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Responsible party
Sponsor
First posted
Mar 6, 2019
Start date
Mar 13, 2019
Primary completion
Apr 11, 2024
Completion
Nov 11, 2024
Last update
Nov 14, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion