NCT06104930

Plasma Extracellular Vesicles in Meningioma Patients

Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. In this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.

Detailed description

In total, 60 patients with meningiomas and an indication of radiotherapy (RT) and macroscopic tumor on the planning MRI will be enrolled. Blood samples will be obtained before the start, during, and after radiotherapy, as well as during clinical follow-up every 6 months. Extracellular vesicles will be isolated from the blood samples, quantified and correlated with the clinical treatment response or progression. Further, nanopore sequencing-based DNA methylation profiles of plasma EV-DNA will be generated for methylation-based meningioma classification. This study will explore the dynamic of plasma EVs in meningioma patients under/after radiotherapy, with the objective of identifying potential biomarkers of (early) tumor progression. DNA methylation profiling of plasma EVs in meningioma patients may enable molecular risk stratification, facilitating a molecularly-guided clinical management in meningioma patients in the future.

Conditions

• Meningioma

Interventions

Type	Name	Description
OTHER	Explorative biomarker study	Analysis of blood biomarker

Timeline

• Start date: 2023-11-01
• Primary completion: 2027-11-01
• Completion: 2028-02-01
• First posted: 2023-10-27
• Last updated: 2026-03-10

Locations

1 site across 1 country: Germany