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Plasma Extracellular Vesicles in Meningioma Patients

RECRUITINGN/ASponsored by University Hospital Heidelberg
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital Heidelberg
Started2023-11-01
Est. completion2027-11-01
Eligibility
Healthy vol.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.

Eligibility

Healthy volunteers accepted
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

Conditions2

CancerMeningioma

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