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NCT Number: NCT06501521

Non-invasive Brain Tumor Molecular Diagnostics and Monitoring

This prospective multicenter study aims to enroll GBM patients who will undergo repeated assessments (preoperatively and 3 months post-surgery) to detect circulating tumor cells and analyze the transcriptomic profiles of EVs in their blood. The prognostic and monitoring significance of these biomarkers to disease course (assessing treatment efficacy, resistance incidence, tumor progression) will be evaluated.

Concurrently, proteomic profiles typical of GBM will be analyzed in blood and ocular secretion samples from GBM patients, patients with low-grade gliomas, and patients without brain tumors to identify and validate novel protein biomarkers suitable for disease monitoring. Additionally, this study proposes an innovative approach to monitor GBM patients by investigating the presence of GBM-specific nucleic acid fragments in urine.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery, University Hospital Olomouc

Olomouc, 77900, Czechia

Location status: Recruiting

Location contact

Ondrej Kalita, MD, PhD

CONTACT

[email protected]

+420588443568

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients with brain tumors -

Exclusion criteria

No other cancer; no inflammatory disease

-

Treatment and study plan

Diagnostic Test

Diagnostic Test

No intervention among the arms. The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed.

Primary outcomes

  1. Proteomic profiles of proximal liquids in brain tumor patients

    Time frame: 2020-2023

    The protein profiles will be measured in ocular secretion and plasma samples of patients wiht GBM, low-grade glioma and control cohort. Candidate proteins will be correleted with clinical parameters. The number of patients with identified prognostic biomarkers will be reported.

  2. Circulating tumor cells (CTCs) for non-invasive monitoring of GBM patients.

    Time frame: 2020-2030

    The number of CTCs and their molecular characteristics will be measured in peripheral blod of GBM patients. The CTCs counts will be correleted with the clinical parameters. The number of patients with the presence or absence of CTCs will be reported.

  3. Extracellular vesicles (EVs) for non-invasive monitoring of GBM patients.

    Time frame: 2020-2030

    The RNA profiles of EVs will be measured in plasma samples of patients wiht GBM. Candidate RNAs will be correleted with clinical parameters. The number of patients with identified prognostic RNAs will be reported.

  4. Urine as a source of GBM-specific nucleic acids fragments for disease monitoring.

    Time frame: 2025-2030

    The GBM-specific nucleic acids fragments will be measured in urine of GBM patients. Candidate nucleic acids will be correleted with clinical parameters. The number of patients with identified prognostic biomolecules will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Josef Srovnal, MD,PhD

CONTACT

[email protected]

+420585632137

Ondrej Kalita, MD,PhD

CONTACT

[email protected]

+420588443568

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Registry information

Official study title

Non-invasive Brain Tumor Diagnosis Through Analysis of Proximal Fluids, Circulating Tumor Cells, and Biomolecules

Important dates

Study start
2020
Primary completion
2028
Study completion
2030
First posted
Jul 15, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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