Non-invasive Brain Tumor Molecular Diagnostics and Monitoring

Recruiting

• Conditions: Brain Tumor
• Interventions: Diagnostic Test: Diagnostic test

• Registration Number: NCT06501521
• Lead Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Adult patients with brain tumors -

Exclusion Criteria

No other cancer; no inflammatory disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glioblastoma multiforme	Diagnostic test	Patients with GBM
Control group	Diagnostic test	Patients without cancer or systemic inflammation
Low-grade glioma	Diagnostic test	Patients with low-grade gliomas.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurosurgery, University Hospital Olomouc; 🇨🇿 Olomouc, Czechia