Cerebrospinal Fluid Biomarkers for Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery
研究概览
简要总结
This study examines cerebrospinal biomarkers in patients with brain tumors. A biomarker is a measurable indicator of the severity or presence of your disease state. Collecting and storing samples of cerebrospinal fluid from patients with brain tumors to study in the laboratory may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.
详细描述
PRIMARY OBJECTIVE:
I. To collect cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery in patients with gliomas.
SECONDARY OBJECTIVE:
I. Evaluate the feasibility of serial CSF sampling from patients with brain tumors for longitudinal evaluation of tumor biomarkers.
OUTLINE:
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any evidence of neoplasm involving the central nervous system (CNS) or its adjacent structures in contact with CSF. Such lesions may include but are not limited to intra-axial or extra-axial lesions, which could be benign, malignant or as yet undefined, involving the brain, spine, meninges, nerves, or vasculature or supporting structures
- •Subjects must be 18 years of age or older
排除标准
- •Patients who are under 18 years of age or are a member of a vulnerable population will be excluded from this study
- •Pregnant women or women who may be pregnant are specifically excluded from study participation
- •Exception will be granted for patients with diminished capacity to consent if a legally authorized representative is available
- •Patients without clinical or radiographic evidence of a potentially neoplastic CNS lesion will be excluded
- •Patients with an inability or unwillingness of individual or legal guardian/representative to give written informed consent will be excluded
- •Any patient for whom a clinical contraindication exists to the intended route of CSF access will be excluded. For example, a patient with a large posterior fossa mass lesion at risk of herniation, or a patient with coagulopathy, or other contraindication to lumbar puncture would not be eligible to participate via use of lumbar puncture for CSF access
研究组 & 干预措施
Basic science (biospecimen collection)
Patients undergo collection of CSF samples via lumbar puncture (LP) at least 2 times. Patients may undergo additional collection of additional CSF samples if they choose. For pediatric patients, LP will not be performed for the purpose of this study; only residual/waste CSF from a clinical LP can be obtained.
干预措施: Biospecimen Collection (Procedure)
Basic science (biospecimen collection)
Patients undergo collection of CSF samples via lumbar puncture (LP) at least 2 times. Patients may undergo additional collection of additional CSF samples if they choose. For pediatric patients, LP will not be performed for the purpose of this study; only residual/waste CSF from a clinical LP can be obtained.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery
时间窗: Up to study completion
次要结局
- Feasibility of serial cerebrospinal fluid (CSF) sampling(Up to study completion)