Investigating blood markers in meningioma patients undergoing radiotherapy
Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy
This study is testing if certain blood markers can help doctors understand how meningioma tumors respond to radiotherapy in patients receiving treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT06104930 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of plasma extracellular vesicles (EVs) in patients with meningiomas who are receiving radiotherapy. A total of 60 patients with confirmed meningiomas and indications for radiotherapy will have blood samples collected before, during, and after treatment, as well as during follow-up. The study will analyze these samples to identify potential biomarkers for tumor progression and to develop DNA methylation profiles for better risk stratification and clinical management of meningioma patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with confirmed meningiomas requiring radiotherapy and a Karnofsky Performance Score of 60% or higher.
Not a fit: Patients with previous tumor diseases within the last 5 years or those undergoing simultaneous chemo/immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and personalized treatment strategies for meningioma patients.
How similar studies have performed: While the exploration of plasma EVs in cancer is a growing field, this specific approach in meningioma patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Heidelberg
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Max Deng, MD
- Email: maximilian.deng@med.uni-heidelberg.de
- Phone: +496221 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.