Evaluating the Role of Cerebrospinal Fluid (CSF) Cell-free DNA (cfDNA) as a Prognostic Biomarker in Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Overall Survival
研究概览
简要总结
The goal of this study is to determine the utility of cerebrospinal fluid (CSF) cell-free DNA (cfDNA) as a prognostic biomarker in glioblastoma (GBM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Participants must be able to understand and be willing to sign a written informed consent document
- •Age ≥ 18 years
- •MRI with contrast-enhancing lesion concerning for high-grade glioma in absence of known systemic malignancy
- •Clinical consensus of presumed diagnosis of high grade glioma between (1) neuroradiology (2) neurosurgery; and (3) principal investigator
- •No prior tumor directed therapy
- •Planned radiation therapy for glioblastoma
- •Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast
- •Patients must be willing to consent to MSK IRB#12-245
- •Participants must be able to understand and be willing to sign a written informed consent document
- •Age ≥ 18 years
- •Histologic confirmed glioblastoma (WHO grade IV), IDH wild type per IHC
- •No prior tumor-directed therapies except surgical resection or biopsy
- •Patients who have gliadel wafers placed during upfront surgery are excluded
- •Planned radiation therapy for glioblastoma
- •Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast
- •Patients must be willing to consent to MSK IRB#12-245
排除标准
- •Cohorts A and B
- •Any case for which there is a medical contraindication or safety concern regarding a lumbar puncture under standard medical guidelines at MSK
- •Refusal to undergo serial lumbar punctures
研究组 & 干预措施
Cohort A
Cohort A will consist of newly diagnosed patients with Glioblastoma. Eligibility for enrollment prior to pathology diagnosis will be determined by a consensus diagnosis of high grade glioma based on clinical and radiographic evidence between neuroradiologist, neurosurgeon and study PI.
干预措施: Lumber Puncture (Diagnostic Test)
Cohort B
Cohort B will consist of patients with a histologically confirmed diagnosis of IDH WT glioblastoma.
干预措施: Lumber Puncture (Diagnostic Test)
结局指标
主要结局
Overall Survival
时间窗: 6 months
Overall survival will be calculated as the time from pathological diagnosis to the date of death due to any cause (prior to analysis cut-off) or last follow-up
次要结局
未报告次要终点