Measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identification of genetic biomarkers from brain tumor and cerebrospinal fluid samples
研究概览
简要总结
Protocol No: SLS-JHM-01
Title: Measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients
Study Sponsor: Johns Hopkins University, School of Medicine
Study Type: Observational, non-interventional, multicentric
Study sites: Upto 8 sites
Total number of subjects: 100
Study Arms: 2
1st Arm: Brain Tumor Malignancy with chemo/radiotherapy
2nd Arm: Brain Tumor Malignancy with lumbar puncture
Rationale:
Tumor DNA load in body fluids (circulating tumor DNA or ctDNA) can be a minimally invasive adjunct biomarker for determining tumor burden and also for determining tumor mutations targetable by therapy.
Objectives:
Primary objective: To test the feasibility of measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients
Secondary objective: To determine progression-free survival (PFS) and overall survival (OS) in patients with tumor-specific genetic alterations detected in the cerebrospinal fluid
Study Design:
This is a multi institutional study to evaluate the feasibility of measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients. Patients with suspected or confirmed malignant brain tumor who are eligible for surgical tumor resection, treatment with chemo or radiation therapy, patients with malignant brain tumors who are undergoing the therapeutic or diagnostic lumbar puncture, will be enrolled into this study. The primary goal of this study is to determine the feasibility of detecting and quantifying ctDNA in CSF of patients with malignant brain tumors. Tumor tissue and CSF will be collected.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age >18 years for Cohort 1: patients with suspected or confirmed malignant brain tumor who are eligible for surgical resection, chemotherapy or radiation treatments, as identified by the site PI or Co-Is through routine clinical care processes
- •Age >12 years for Cohort 2: patients, including children, with malignant brain tumor, who are undergoing a diagnostic or therapeutic lumbar puncture, as identified by the site PI or Co-Is through routine clinical care processes
- •Life expectancy of greater than 6 months
- •Patients must have normal lab criteria as defined below: 4a) Platelets ≥ 100,000/mcL 4b) PTT above institutional limits 4c) INR above institutional limits 5) Ability to understand and the willingness to sign a written Informed Consent Form for patients >18 years and an Assent form for patients <18 years 6) Both men and women of all races and ethnic groups are eligible for this study.
排除标准
- •Patients who have an uncontrolled infection 2) Patients who are receiving an investigational agent(s) that increases the risks associated with cerebrospinal fluid sampling 3) Patients with clinical or radiographic evidence of elevated intracranial pressure (such as papilledema, obstructive hydrocephalus, or signs of herniation) 4) Patients who are coagulopathic and are taking blood thinning products, such as plavix, lovenox, or coumadin.
- •Patients maybe on steroids or anti-convulsant therapy without affecting eligibility 5) Women who are pregnant or suspect they are pregnant or lactating mothers.
结局指标
主要结局
Identification of genetic biomarkers from brain tumor and cerebrospinal fluid samples
时间窗: By the end of the duration of the study
次要结局
- Not Applicable(Not Applicable)