Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

Completed

• Conditions: Glioma; Glioblastoma Multiforme
• Interventions: Other: Non- interventional

• Registration Number: NCT03865355
• Lead Sponsor: Novosibirsk State University

Brief 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.

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 Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Study Start: 2019-03-13
• Primary Completion: 2024-04-11
• Status Verified: 2024-11
• Study Completion: 2024-11-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2 / Low grade Glioma	Non- interventional	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
Cohort 1 / High grade Glioma	Non- interventional	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)
Cohort 3 / Conditionally healthy volunteers	Non- interventional	Cohort 3: 1. No oncological disease was diagnosed 2. Planned treatment (reconstructive surgery after craniofacial trauma)

Primary Outcome Measures

Name	Time	Method
Metabolic phenotype of glioma patients	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 Outcome Measures

Name	Time	Method
Progression free survival (PFS)	5 years	Time between date of diagnosis and date of disease progression
Overall survival (OS)	5 years	Time between date of diagnosis and date of death

Trial Locations

Locations (1)

Novosibirsk State University; 🇷🇺 Novosibirsk, Novosibirskaya Oblast', Russian Federation