Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

NCT03865355 | Completed

• 1 other identifier: MetGlio/19
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Glioblastoma Multiforme

Keywords

Metabolomic profile; Biomarkers

Outcome Measures

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.

  5 years

Secondary Outcomes (2)

• Overall survival (OS)

  5 years

• Progression free survival (PFS)

  5 years

Study Arms (3)

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

Non- interventional OTHER

Translational, observational study

Cohort 1 / High grade Glioma; Cohort 2 / Low grade Glioma; Cohort 3 / Conditionally healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Novosibirsk State University

Novosibirsk, Novosibirsk Oblast, 630090, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, cerebrospinal fluid (CSF)

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 6, 2019
• Study Start: March 13, 2019
• Primary Completion: April 11, 2024
• Study Completion: November 11, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

RU (1)