Plasma Extracellular Vesicles in Meningioma Patients

Meningioma Clinical Trial

— MOLI  

Official title:

Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104930
• Other study ID #: RADONK-MOLI-2023
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: November 2023
• Source: University Hospital Heidelberg
• Contact: Max Deng, MD
• Phone: +496221 56
• Email: maximilian.deng[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Meningioma

Intervention

Other:
• Explorative biomarker study
Analysis of blood biomarker

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dynamic of plasma EVs	Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy	until 2 years follwoing radiotherapy
Secondary	progession-fee survival	number of patients without tumor progress	until 2 years follwoing radiotherapy
Secondary	overall survival	number of alive patients	until 2 years follwoing radiotherapy