Assessing the CSF-ctDNA of Patients With Stage III and IV Non-Small Cell Lung Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of subjects with Intracranial disease in locally advanced lung cancer patients
研究概览
简要总结
This phase I trial assesses the use of lumbar punctures to detect whether there is circulating tumor deoxyribonucleic acid (ctDNA) in the fluid that surrounds the brain and spinal cord (cerebrospinal fluid) in patients with stage III and IV non-small cell lung cancer (NSCLC). Patients with stage III and IV NSCLC are at risk of having their cancer spread from where it first started to the brain (metastatic). Because of this, more effective prognostic tools are necessary to determine which stage III and IV NSCLC patients are more likely to develop brain metastases. Cerebrospinal fluid (CSF) could be a reliable source of ctDNA to confirm and predict the presence of brain metastases in these patients. Assessing cell free DNA shed from tumor cells could be a sensitive and minimally invasive way to detect or characterize metastatic tumors in the central nervous system (CNS). Lumbar puncture is procedure in which a thin needle called a spinal needle is put into the lower part of the spinal column to collect CSF. Lumbar punctures for the collection of CSF may help doctors detect or measure changes in cell types, genes, and proteins of circulating tumor cells related to lung cancer that will help determine the presence of brain metastases which could become a standard of care screening tool utilized in the follow-up of patients diagnosed with stage II or IV NSCLC.
详细描述
PRIMARY OBJECTIVES:
I. To determine if CSF-ctDNA positivity in patients with locally advanced lung cancer can predict the presence of brain metastases within a one year period.
II. To prospectively confirm that cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) can be detected in patients diagnosed with metastatic non-small cell lung cancer (NSCLC) to the brain utilizing next generation sequencing (NGS) and single gene quantitative/biomarker analyses through the CNSide (trademark) platform.
SECONDARY OBJECTIVES:
I. To use the CNSide (trademark) platform to assess for the presence of circulating tumor cells in both CSF and peripheral blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New histological diagnosis of stage III or IV NSCLC
- •For stage III/IV NSCLC patients without brain metastases, a documented mutation on lung cancer mutation panel (PULMOL) is required
- •Patient treated with radiation therapy and/or systemic therapy at Ohio State University
- •Estimated survival >= 1 year
- •No medical contraindication to lumbar puncture
排除标准
- •Patient has Alzheimer's, dementia, or mental disability
- •Patient is not able to receive MRI
- •Patient has allergy to xylocaine or any numbing medication for lumbar puncture
- •Previous cancer history prior to diagnosis of NSCLC
- •Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the medication and radiation required for standard of care treatment has unknown effects on the unborn fetus
研究组 & 干预措施
Cohort 1: Stage III/IV without brain metastases (LP)
Patients undergo LP for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo MRI during screening and 12 month follow-up.
Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
干预措施: Magnetic Resonance Imaging (Device)
Cohort 1: Stage III/IV without brain metastases (LP)
Patients undergo LP for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo MRI during screening and 12 month follow-up.
Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
干预措施: Biospecimen Collection (Procedure)
Cohort 1: Stage III/IV without brain metastases (LP)
Patients undergo LP for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo MRI during screening and 12 month follow-up.
Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
干预措施: Lumbar Puncture (Procedure)
Cohort 2: Stage IV NSCLC with brain metastases (LP)
Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening.
Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
干预措施: Biospecimen Collection (Procedure)
Cohort 2: Stage IV NSCLC with brain metastases (LP)
Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening.
Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
干预措施: Lumbar Puncture (Procedure)
Cohort 2: Stage IV NSCLC with brain metastases (LP)
Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening.
Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
干预措施: Magnetic Resonance Imaging (Device)
结局指标
主要结局
Number of subjects with Intracranial disease in locally advanced lung cancer patients
时间窗: Up to 6 months
An MRI will be performed six months after lumbar puncture in Cohort One. MRI sequences with T1 post-contrast for disease and structure definition and T2/FLAIR sequences for identification of peri-tumoral edema or cystic volumes will be obtained.
Cerebral spinal fluid- circulating tumor deoxyribonucleic acid (ctDNA) detection rate for lung non-small cell carcinoma patients with metastatic disease to the brain
时间窗: Up to 12 months
Will estimate the frequency of ctDNA detection with a 90% Clopper-Pearson confidence interval.
次要结局
未报告次要终点
研究者
Joshua Palmer
Principal Investigator
Ohio State University Comprehensive Cancer Center