Plasma Extracellular Vesicles in Meningioma Patients (MOLI)

University Hospital Heidelberg

Status

Enrolling

Conditions

Meningioma

Treatments

Other: Explorative biomarker study

Study type

Interventional

Funder types

Other

Identifiers

NCT06104930

RADONK-MOLI-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

confirmed meningioma (histologically or MRI/DOTATOC-PET CT)
macroscopic tumor in MRI (either as definitive RT, or following subtotal resection or relapse)
indication for radiotherapy
completed wound healing after surgical intervention)
Alter ≥ 18 Jahre
Karnofsky Performance Score ≥ 60%
written informed consent
ability of subject to understand character and individual consequences of the trial
adequate contraception for women of childbearing potential

Exclusion criteria

previous or known tumor diseases < 5 years ago
previous (cerebral) radiotherapy
simultaneous chemo/immunotherapy
evidence that the patient cannot adhere to the study protocol (e.g., non-compliance)
the refusal of patients to participate in the study
participation in another clinical study or observation period in a competing trial