Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

Glioma Clinical Trial

Official title:

Unique Blood and CSF Metabolic Profile Association With Gliomas in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865355
• Other study ID #: MetGlio/19
• Status: Recruiting
• Start date: March 13, 2019
• Est. completion date: April 11, 2029

Study information

• Verified date: March 2023
• Source: Novosibirsk State University
• Contact: Olga Oleshko, MD
• Phone: +7 (913) 484-67-59
• Email: o.oleshko[@]g.nsu.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 11, 2029
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Glioma

Intervention

Other:
• Non- interventional
Translational, observational study

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State University	Novosibirsk	Novosibirskaya Oblast'

Sponsors (3)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	Time between date of diagnosis and date of death	5 years
Secondary	Progression free survival (PFS)	Time between date of diagnosis and date of disease progression	5 years