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Plasma Extracellular Vesicles in Meningioma Patients

ConditionMeningioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Hospital Heidelberg

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Explorative biomarker study

    Other intervention

    Analysis of blood biomarker

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsyOther 1 intervention

Trial outcomes

Primary outcomes

1

dynamic of plasma EVs

Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy

Time frame
until 2 years follwoing radiotherapy

Secondary outcomes

1

progession-fee survival

number of patients without tumor progress

Time frame
until 2 years follwoing radiotherapy
2

overall survival

number of alive patients

Time frame
until 2 years follwoing radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Heidelberg

Lead sponsor

Source ClinicalTrials.gov
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