Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- dynamic of plasma EVs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsy
Explorative biomarker study
干预措施: Explorative biomarker study (Other)
结局指标
主要结局
dynamic of plasma EVs
时间窗: until 2 years follwoing radiotherapy
Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy
次要结局
- overall survival(until 2 years follwoing radiotherapy)
- progession-fee survival(until 2 years follwoing radiotherapy)
研究者
Juergen Debus
Department head
University Hospital Heidelberg