Non-invasive Brain Tumor Molecular Diagnostics and Monitoring

ConditionBrain Tumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Inhabitants of Olomouc region

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Diagnostic test

    Diagnostic test

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

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Glioblastoma multiforme1 intervention
Group B: Low-grade glioma1 intervention
Group C: Control group1 intervention

Trial outcomes

Primary outcomes

1

Proteomic profiles of proximal liquids in brain tumor patients

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.

Time frame
2020-2023
2

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

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.

Time frame
2020-2030
3

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

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.

Time frame
2020-2030
4

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

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.

Time frame
2025-2030

Secondary outcomes

Other outcomes

Sponsors and contacts

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