Plasma Extracellular Vesicles in Meningioma Patients

NCT06104930 | Recruiting

• 1 other identifier: RADONK-MOLI-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meningioma

Outcome Measures

Primary Outcomes (1)

• dynamic of plasma EVs

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

  until 2 years follwoing radiotherapy

Secondary Outcomes (2)

• progession-fee survival

  until 2 years follwoing radiotherapy

• overall survival

  until 2 years follwoing radiotherapy

Study Arms (1)

Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsy

OTHER

Explorative biomarker study

Other: Explorative biomarker study

Interventions

Explorative biomarker study OTHER

Analysis of blood biomarker

Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Central Study Contacts

Max Deng, MD

CONTACT

+496221 56; maximilian.deng@med.uni-heidelberg.de

Adriane Lentz-Hommertgen, PhD

CONTACT

+496221 56; adriane.lentz-hommertgen@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department head

Model Details: Prospective Explorative Biomarker Study / Investigator-Initiated Trial

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 27, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)