Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA
研究概览
简要总结
Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.
详细描述
Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. Advances in DNA sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctDNA as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators aim to evaluate whether driver gene mutations detected by PEAC can replace tissue testing results in patients with stage I to Ⅲ NSCLC. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection;
- •No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;
- •Men or women of age ≥18 years and <75 years old;
- •Eastern Cooperative Oncology Group (ECOG) behavior status score 0 to 1.
排除标准
- •Patients with other cancers other than NSCLC within five years prior to this study;
- •Who can not get enough tumor histological specimens (non-cytological) for analysis;
- •Human immunodeficiency virus (HIV) infection;
- •NSCLC mixed with patients with small cell lung cancer;
- •Pregnant or lactating women;
- •There is a clear history of neurological or mental disorders, including epilepsy or dementia;
- •Conditions that investigators think is not suitable for inclusion.
结局指标
主要结局
Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA
时间窗: 2 years after the last patient enrolled
PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline.
ctDNA dynamic monitoring
时间窗: 2 years after the last patient enrolled
PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline
次要结局
未报告次要终点
研究者
Si-Yu Wang
Professor
Sun Yat-sen University