Prospective Observational Study for the Implementation of Liquid Biopsy in the Follow-up of Patients With High-grade Gliomas and Meningiomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- cfDNA correlation with PFS
研究概览
简要总结
The general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas.
To this end, we propose to longitudinally collect four samples of plasma at the following time points:
- T0: before surgery;
- T1: one month after surgery;
- T2: one month after the end of radiotherapy;
- T3 at the time of radiological progression.
The goal is to evaluate whether changes in plasma concentration of circulating cell-free DNA can help predict progression-free survival, overall survival, and response to therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Finding, on an MRI scan of the brain with gadolinium, of a brain lesion compatible with a primary brain tumor, intra- or extra-axial, suspected for a high-grade glioma or a high-grade meningioma, manifested with new onset neurological symptoms
- •Clinical indication to perform a biopsy or surgical resection of the lesion
- •Karnofsky Performance Status (KPS) ≥ 60
- •Signature of informed consent
排除标准
- •Absolute contraindications to magnetic resonance imaging or to the administration of gadolinium (e.g. patients with pacemakers or other non-magneto-compatible devices)
- •Known positivity for HIV, HCV or HBV
- •There are clinical, biological or instrumental data suggesting that the brain lesion is non-neoplastic in nature (e.g., abscess, vascular malformation, inflammatory disease of the Central Nervous System)
- •Women who are pregnant or breastfeeding
结局指标
主要结局
cfDNA correlation with PFS
时间窗: 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
To evaluate whether circulating free DNA concentration in plasma at diagnosis correlates with progression-free survival.
次要结局
- correlation between change in cfDNA concentration one month after radiotherapy completion and tumor volume changes, as well as clinical status changes(values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery)
- cfDNA concentration changes at progression(values at the time of suspected radiological progression (or at month 12 in the absence of suspected radiological progression) compared with values assessed at month 3.5 after surgery (+/- one week))
- cfDNA correlation with OS(1-3 days before surgery until patient death (or at month 12 if patient is alive))
- correlation between change in cfDNA concentration after surgery and PFS and OS(from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression))
研究者
Gaetano Finocchiaro
MD
IRCCS San Raffaele