Non-invasive Brain Tumor Molecular Diagnostics and Monitoring

NCT06501521 | Recruiting

• 1 other identifier: NW25-03-00198
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Glioblastoma multiforme

Patients with GBM

Diagnostic Test: Diagnostic test

Low-grade glioma

Patients with low-grade gliomas.

Diagnostic Test: Diagnostic test

Control group

Patients without cancer or systemic inflammation

Diagnostic Test: Diagnostic test

Interventions

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; Glioblastoma multiforme; Low-grade glioma

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inhabitants of Olomouc region

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead

Study Sites (1)

Department of Neurosurgery, University Hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. ocular secretion 2. peripheral blood 3. urine

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marian Hajduch, MD,PhD

  Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josef Srovnal, MD,PhD

CONTACT

+420585632137; josef.srovnal@upol.cz

Ondrej Kalita, MD,PhD

CONTACT

+420588443568; ondrej.kalita@fnol.cz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 15, 2024
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

CZ (1)