Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate of change of seizure frequency
研究概览
简要总结
This study investigates how seizures can vary over time with changes in low grade gliomas and its treatments. This study may help doctors find symptoms or triggers of seizures earlier than normal, and ultimately earlier care or treatment for seizures.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the rate of change of seizure frequency and the status of the tumor at each data collection point.
SECONDARY OBJECTIVES:
I. To obtain sufficient number of patients' data in order to power the analysis to determine whether a change in seizure frequency correlates with tumor control.
II. Evaluate progression free survival and overall survival when compared with seizure control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Primary brain tumors (separated by World Health Organization [WHO] grade I-IV)
- •History of seizures secondary to brain tumor
- •On tumor directed treatment
- •Magnetic resonance imaging (MRI) within 2 weeks of clinic visit where seizure assessment takes place
排除标准
- •Patients without seizures
- •Patients with intracranial lesions other than primary brain tumor
- •Patients not undergoing tumor directed treatment
- •Absence of recent (within 2 weeks) MRI
研究组 & 干预措施
Observational (survey)
Patients complete a seizure assessment survey over 5 minutes at each clinic visit.
干预措施: Survey Administration (Other)
结局指标
主要结局
Rate of change of seizure frequency
时间窗: Baseline to 2 years
Both average composite scores as well as individual question scores from the seizure survey will be evaluated. Will perform descriptive statistics to characterize the demographic and disease-related features of this population. Will perform regression analyses to the relationship of survey results to clinical and radiographic features. Cox regression analyses for other relevant post-hoc analyses may be performed.
Status of tumor
时间窗: Up to 2 years
Radiographic information will be derived from brain MRIs performed on each patient at time of diagnosis, and subsequently at times of survey administration. Will perform descriptive statistics to characterize the demographic and disease-related features of this population. Will perform regression analyses to the relationship of survey results to clinical and radiographic features. Cox regression analyses for other relevant post-hoc analyses may be performed.
次要结局
- Patient data collection(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)