Assessment of MGMT Promoter Methylation and Clinical Benefit From Temozolomide-based Therapy in Ewing Sarcoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 5
- 主要终点
- Assessment of MGMT promoter methylation
研究概览
简要总结
This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan The O6-methylguanine-DNA methyltransferase (MGMT) methylation status, will be correlated with the disease clinical data and with the disease response
详细描述
This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan.
The MGMT methylation status will be correlated with the disease clinical data and with the disease response also in term of metabolic activity (if data will be available) The MGMT methylation analysis will be performed extracting from fresh tumor sample, the DNA on the basis of the standard protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmed diagnosis of Ewing Sarcoma
- •Chemotherapic treatment with temozolomide and irinotecan
- •Written informed consent prior to any study related activities
排除标准
- •Lack of written informed consent for the study
- •Any situation that could interfere with the complete data collection of the clinical data related to the temozolomide and irinotecan treatment
结局指标
主要结局
Assessment of MGMT promoter methylation
时间窗: at day 1
Amplification the methylation-specific Polymerase Chain Reaction products will be electrophoresed on a 2% agarose gel and will visualized with UV light
次要结局
- Correlation of the MGMT promoter methylation to the activity of the temozolomide irinotecan combination(at month 2, 4, 6, 8, 10 and 12)