Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

March 22, 2023 updated by: Novosibirsk State University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
    • Novosibirskaya Oblast'
      • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630090
        • Recruiting
        • Novosibirsk State University
        • Contact:
        • Principal Investigator:
          • Andrey Pokrovsky, DSc in Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Translational, observational study
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
Translational, observational study
Cohort 3 / Conditionally healthy volunteers

Cohort 3:

  1. No oncological disease was diagnosed
  2. Planned treatment (reconstructive surgery after craniofacial trauma)
Other: Non- interventional
Translational, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 years
Time between date of diagnosis and date of death
5 years
Progression free survival (PFS)
Time Frame: 5 years
Time between date of diagnosis and date of disease progression
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novosibirsk State University

Collaborators

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
FSBI "Federal Neurosurgical Center" Novosibirsk, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Anticipated)

April 11, 2024

Study Completion (Anticipated)

April 11, 2029

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MetGlio/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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