Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

Novosibirsk State University

Status: Completed

Conditions: Glioma; Glioblastoma Multiforme

Treatments: Other: Non- interventional

Study type: Observational

Funder types: Other

Identifiers

NCT03865355

MetGlio/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 3 patient groups

Cohort 1 / High grade Glioma

Description:

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)

Treatment:

Other: Non- interventional

Cohort 2 / Low grade Glioma

Description:

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

Treatment:

Other: Non- interventional

Cohort 3 / Conditionally healthy volunteers

Description:

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

Treatment:

Other: Non- interventional