The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Tumor heterogeneity of multiple primary lung cancer
研究概览
简要总结
To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC.
详细描述
Multiple primary lung cancer (MPLC) has become a worldwide problem due to the difficulty in diagnosis, treatment and surveillance. Although exploring tumour clonal heterogeneity and microenvironment can help understand cancer evolution and impact therapeutic outcome, study is still lacking in this field on MPLC. Circulating tumor DNA (ctDNA) are short DNA fragments, which can be obtained conveniently and non-invasively, providing comprehensive views of the tumor as were shed by tumor cells from multiple tumor regions. Therefore, we design a prospective study of patients with surgically treated MPLC, aiming to use ctDNA technique to define the evolutionary landscape of MPLC through inter-tumor and intra-tumor heterogeneity by multi-region sampling and genetic analysis. We will also explore the the microenvironment by RNA sequencing and T cell receptor sequencing. This study may help understand the genetic evolution and microenvironment of MPLC, and provide evidence for the diagnosis, treatment and surveillance of these patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years
- •Patients who are clinically diagnosed multiple lung cancers, and undergo surgical treatment.
- •No history of any malignancy in recent 5 years.
- •No chemotherapy, radiotherapy or targeted therapy will be performed before surgery.
- •Surgical removal of at least 2 tumors confirmed to be lung cancer postoperatively by pathologic evaluation.
排除标准
- •All lesions present as pure ground-glass opacities (GGOs) on CT scans.
- •Patients who do not undergo R0 resection (including tumors located bilaterally but only unilaterally resected).
- •Unqualified blood samples.
- •Unable to comply with the study procedure
结局指标
主要结局
Tumor heterogeneity of multiple primary lung cancer
时间窗: 3 year
Explore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.
Microenvironment of multiple primary lung cancer
时间窗: 3 year
Using RNA sequencing and T cell receptor (TCR) sequencing to evaluate the microenvironment of each lesion of multiple primary lung cancer, including T cell receptpr clonality ,diversity , evenness, and richness.
次要结局
- Correlation between ctDNA and clonal variation(3 year)
- Correlation between ctDNA and tumor burden(3 year)