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NCT Number: NCT03865355

Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novosibirsk State University

Novosibirsk, Novosibirsk Oblast, 630090, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Non- interventional

Other

Translational, observational study

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

    Time between date of diagnosis and date of death

  2. Progression free survival (PFS)

    Time frame: 5 years

    Time between date of diagnosis and date of disease progression

Sponsors and collaborators

Lead sponsor

Novosibirsk State University

Other

Collaborators

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

Registry information

Official study title

Unique Blood and CSF Metabolic Profile Association With Gliomas in Adults

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2019
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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