Non-invasive Brain Tumor Molecular Diagnostics and Monitoring

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Diagnostic test: Diagnostic test

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Josef Srovnal, MD,PhD; Phone Number: +420585632137; Email: josef.srovnal@upol.cz
• Study Contact Backup: Name: Ondrej Kalita, MD,PhD; Phone Number: +420588443568; Email: ondrej.kalita@fnol.cz

Study Locations

• Czechia
  • Olomouc, Czechia, 77900
    • Recruiting
    • Department of Neurosurgery, University Hospital Olomouc
    • Contact: Ondrej Kalita, MD, PhD; Phone Number: +420588443568; Email: ondrej.kalita@fnol.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Inhabitants of Olomouc region

Description

Inclusion Criteria: Adult patients with brain tumors -

Exclusion Criteria: No other cancer; no inflammatory disease

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glioblastoma multiforme; Patients with GBM	Diagnostic test: Diagnostic test; No intervention among the arms. The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed.
Low-grade glioma; Patients with low-grade gliomas.	Diagnostic test: Diagnostic test; No intervention among the arms. The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed.
Control group; Patients without cancer or systemic inflammation	Diagnostic test: Diagnostic test; No intervention among the arms. The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2020-2023
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.	2020-2030
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.	2020-2030
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.	2025-2030

Collaborators and Investigators

• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
• Investigators: Principal Investigator: Marian Hajduch, MD,PhD, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: NW25-03-00198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymous proteomic profiles of plasma and ocular secretion and transcriptomic data from extracelular vesicles will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No