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
Study Type
Enrollment (Estimated)
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
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Olomouc, Czechia, 77900
- Recruiting
- Department of Neurosurgery, University Hospital Olomouc
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Contact:
- Ondrej Kalita, MD, PhD
- Phone Number: +420588443568
- Email: ondrej.kalita@fnol.cz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Adult patients with brain tumors -
Exclusion Criteria: No other cancer; no inflammatory disease
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Glioblastoma multiforme
Patients with GBM
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No intervention among the arms.
The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed.
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Low-grade glioma
Patients with low-grade gliomas.
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No intervention among the arms.
The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed.
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Control group
Patients without cancer or systemic inflammation
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No intervention among the arms.
The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proteomic profiles of proximal liquids in brain tumor patients
Time Frame: 2020-2023
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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.
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2020-2023
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Circulating tumor cells (CTCs) for non-invasive monitoring of GBM patients.
Time Frame: 2020-2030
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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.
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2020-2030
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Extracellular vesicles (EVs) for non-invasive monitoring of GBM patients.
Time Frame: 2020-2030
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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.
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2020-2030
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Urine as a source of GBM-specific nucleic acids fragments for disease monitoring.
Time Frame: 2025-2030
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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.
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2025-2030
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Collaborators and Investigators
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)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NW25-03-00198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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