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Trial Title:
Plasma Extracellular Vesicles in Meningioma Patients
NCT ID:
NCT06104930
Condition:
Meningioma
Conditions: Official terms:
Meningioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Prospective Explorative Biomarker Study / Investigator-Initiated Trial
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Explorative biomarker study
Description:
Analysis of blood biomarker
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital of Heidelberg, Radiation Oncology
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Jürrgen Debus, MD PHD
Email:
Principal Investigator
Start date:
November 1, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
University Hospital Heidelberg
Agency class:
Other
Source:
University Hospital Heidelberg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06104930
