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临床试验/NCT03029065
NCT03029065Unknown不适用

Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis

Shandong Cancer Hospital and Institute0 个研究点目标入组 50 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
investigate new diagnosis method for lung adenocarcinoma with brain (meningeal) metastasis

研究概览

简要总结

This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

详细描述

This study planned to enroll 50 patients with lung cancer diagnosed with brain (meningeal) metastases, and all cases were slated to receive radiotherapy and targeted therapy. Patients' clinical data were collected (including but not limited to: age at diagnosis with brain (meningeal) metastases, KPS score, smoking history, stage of disease at diagnosis, time to progress to brain metastases, number of brain metastases, extracranial metastases (ECM), and systemic disease at the time of brain metastases. Anticoagulated whole blood and anticoagulated cerebrospinal fluid were collected before local treatment (samples of primary cancer tissue and metastatic carcinoma of some patients were preserved) and at 7 days, 1 month, 3 months, as well as 6 months after the treatment (time of sample retention was to be determined, Figure 2). DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid, for complete quantitative detection of DNA, DNA library construction, as well as targeted capture sequencing. Tumor-related genes were analyzed, and changes in the tumor burden during the treatment process were evaluated. The clinical significance of cfDNA in the plasma and cerebrospinal fluid for treatment efficacy and prognosis was evaluated, and compared with that of clinical indicators of treatment efficacy.

This study involved two stages. The first stage was a pre-experiment: samples were retained from 3-5 cases, and mutations in tumor-related genes in the cfDNA in plasma and cerebrospinal fluid were compared. The investigators analyzed, combined with clinical indicators, whether mutations of cfDNA in plasma accord with that of the cerebrospinal fluid and whether mutations of cfDNA in cerebrospinal can reflect the mutational status of tumor cells. The second phase was conducted by expanding the number of cases, based on the first stage.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with confirmed diagnosis of lung adenocarcinoma with brain (meningeal) metastasis.
  • •Samples collection should be allowed.

排除标准

  • •Pregnant women
  • •Minors (subjects less than 18 years of age)

结局指标

主要结局

investigate new diagnosis method for lung adenocarcinoma with brain (meningeal) metastasis

时间窗: Participants are followed in 6 months after treatment

Investigate whether the cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

次要结局

未报告次要终点

研究者

发起方
Shandong Cancer Hospital and Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rongjie Tao

Shandong Cancer Hospital and Institute

Shandong Cancer Hospital and Institute

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