Analysis of CMV Infections in Patients Suffering From Brain Tumors and Brain Metastases During and After Radio(Chemo)Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Change of CMV status during radio(chemo)therapy (RCT)
研究概览
简要总结
Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. Neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. However CMV encephalitis may also be a reason. Therefore the investigators aim to analyze the CMV status in patients during and after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral blood will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •brain tumours (glioblastoma or anaplastic astrocytoma)
- •brain metastases from diagnosed primary tumours
- •legal age
- •planned chemoradiation and adjuvant chemotherapy [metastases]
- •planned chemoradiation and adjuvant chemotherapy with temodal (according to Stupp et. al.) [brain tumors]
排除标准
- •fertile patients who refuse effective contraception during study treatment
- •persistent drug and/or alcohol abuse
- •patients not able or willing to behave according to study protocol
- •patients in care
- •patients that are not able to speak German
- •patients with claustrophobia
- •patients with artificial joint or any metal parts in the body
- •patients with pacemakers
结局指标
主要结局
Change of CMV status during radio(chemo)therapy (RCT)
时间窗: up to day 45 after start of Radiotherapy
CMV infection will be monitored by virus analysis by an approved laboratory. The analyses were conducted at time points during and after RCT - before RT (day 0), during RT (dose halftime), end of RT (last day of RT), month 3 and 6 after completed RT. This scheme is repeated if patient receives additional RT for relapse treatment. The time points during RT were determined depending on the applied irradiation dose. For glioblastoma the halftime of RT is usually day 23 (received dose 30 Gy) and the end of therapy is usually day 45 (received dose 60 Gy). For cerebral metastases the halftime of the RT is usually day 8 (received dose 9 Gy) and day 16 at the end of therapy (received dose 18 Gy). However, the time points are strongly connected to the received dose.
次要结局
- Change of circulating immune cells of treated patients by deep immunophenotyping.(up to month 6 after the start of Radiotherapy)