University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120, Germany
Location status: Recruiting
Location contact
Jürrgen Debus, MD PHD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06104930
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.
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Interventional
Not applicable
Heidelberg, 69120, Germany
Location status: Recruiting
Jürrgen Debus, MD PHD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Analysis of blood biomarker
Time frame: until 2 years follwoing radiotherapy
Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy
Time frame: until 2 years follwoing radiotherapy
number of patients without tumor progress
Time frame: until 2 years follwoing radiotherapy
number of alive patients
Contact information is provided by the study sponsor or research team.
Adriane Lentz-Hommertgen, PhD
CONTACT
+496221 56 ext. 8201
Max Deng, MD
CONTACT
+496221 56 ext. 8201
University Hospital Heidelberg
Other
Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy
Acronym: MOLI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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