A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing
研究概览
简要总结
Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients
详细描述
Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by a comprehensive NGS Panal . High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 must have given written informed consent
- •Histopathologically confirmed NSCLC
- •Considered multiple or multifocal primary lung cancer by clinical criteria
排除标准
- •Malignant tumor history within the past 5 years
- •Patients who received any treatment prior to resection
- •Insufficient tumor tissue or blood sample
结局指标
主要结局
The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing
时间窗: 18 months
次要结局
- The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients(18 months)
- The relationship between overall survival and genomic results in multiple primary lung cancer patients(5 years)
- The relationship between disease free survival and genomic results in multiple primary lung cancer patients(5 years)
研究者
Chen KeZhong
MD，Thoracic Surgery Service
Peking University People's Hospital