Plasma Extracellular Vesicles in Meningioma Patients

Rekrutierend

NCT-Nummer:
NCT06104930

Studienbeginn:
November 2023

Letztes Update:
18.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Meningioma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Kontakt

Max Deng, MD
Kontakt:
Phone: +496221 56
Phone (ext.): 8201
E-Mail: maximilian.deng@med.uni-heidelberg.de» Kontaktdaten anzeigen

Adriane Lentz-Hommertgen, PhD
Kontakt:
Phone: +496221 56
Phone (ext.): 8201
E-Mail: adriane.lentz-hommertgen@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Heidelberg, Radiation Oncology
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. dynamic of plasma EVs (Time Frame - until 2 years follwoing radiotherapy):
Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy

Secondary outcome:

1. progession-fee survival (Time Frame - until 2 years follwoing radiotherapy):
number of patients without tumor progress

2. overall survival (Time Frame - until 2 years follwoing radiotherapy):
number of alive patients

Geprüfte Regime

Explorative biomarker study:
Analysis of blood biomarker

Quelle: ClinicalTrials.gov