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MOLI: Plasma Extracellular Vesicles in Meningioma Patients

Sponsor
University Hospital Heidelberg (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06104930
Collaborator
(none)
60
Enrollment
1
Location
27
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Explorative biomarker study
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective Explorative Biomarker Study / Investigator-Initiated TrialProspective Explorative Biomarker Study / Investigator-Initiated Trial
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Outcome Measures

Primary Outcome Measures

  1. dynamic of plasma EVs [until 2 years follwoing radiotherapy]

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

Secondary Outcome Measures

  1. progession-fee survival [until 2 years follwoing radiotherapy]

    number of patients without tumor progress

  2. overall survival [until 2 years follwoing radiotherapy]

    number of alive patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Heidelberg, Radiation Oncology Heidelberg Germany 69120

Sponsors and Collaborators

  • University Hospital Heidelberg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juergen Debus, Department head, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT06104930
Other Study ID Numbers:
  • RADONK-MOLI-2023
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Meningioma

Study Results

No Results Posted as of Oct 27, 2023