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NCT Number: NCT06104930

Plasma Extracellular Vesicles in Meningioma Patients

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

Location status: Recruiting

Location contact

Jürrgen Debus, MD PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Explorative biomarker study

Other

Analysis of blood biomarker

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Adriane Lentz-Hommertgen, PhD

CONTACT

[email protected]

+496221 56 ext. 8201

Max Deng, MD

CONTACT

[email protected]

+496221 56 ext. 8201

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy

Acronym: MOLI

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 27, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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