Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03865355
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novosibirsk State University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Glioblastoma Multiforme

Additional Details

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.

Arms & Interventions

Arms

: Cohort 1 / High grade Glioma

Cohort 1: Histologically confirmed high-grade glioma (grade III and grade IV (glioblastoma (GBM))) Planned treatment (surgery followed by radiation therapy (RT) alone or Chemotherapy alone or a combination of RT/Chemotherapy)

: Cohort 2 / Low grade Glioma

Cohort 2: Histologically confirmed low-grade (grade I/II) glioma Planned treatment either expectant monitoring or surgery followed by RT alone or Chemotherapy alone or a combination of RT/Chemotherapy

: Cohort 3 / Conditionally healthy volunteers

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

Interventions

Other: - Non- interventional

Translational, observational study

Contact a Trial Team

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International Sites

Novosibirsk State University, Novosibirsk, Novosibirskaya Oblast', Russian Federation

Status

Recruiting

Address

Novosibirsk State University

Novosibirsk, Novosibirskaya Oblast', 630090

Site Contact

Olga Oleshko, MD

[email protected]

+7 (913) 484-67-59

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