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Non-invasive Brain Tumor Molecular Diagnostics and Monitoring

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06501521
Enrollment
200
Registered
2024-07-15
Start date
2020-01-01
Completion date
2030-12-31
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor

Brief summary

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.

Interventions

DIAGNOSTIC_TESTDiagnostic test

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

Sponsors

The Institute of Molecular and Translational Medicine, Czech Republic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

Adult patients with brain tumors -

Exclusion criteria

No other cancer; no inflammatory disease \-

Design outcomes

Primary

MeasureTime frameDescription
Proteomic profiles of proximal liquids in brain tumor patients2020-2023The 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.
Circulating tumor cells (CTCs) for non-invasive monitoring of GBM patients.2020-2030The 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.
Extracellular vesicles (EVs) for non-invasive monitoring of GBM patients.2020-2030The 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.
Urine as a source of GBM-specific nucleic acids fragments for disease monitoring.2025-2030The 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.

Countries

Czechia

Contacts

Primary ContactJosef Srovnal, MD,PhD
josef.srovnal@upol.cz+420585632137
Backup ContactOndrej Kalita, MD,PhD
ondrej.kalita@fnol.cz+420588443568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026