Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.
研究概览
简要总结
This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.
详细描述
Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.
Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.
This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.
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 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
- •Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
- •Completed and explicit information about TNM staging
- •Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
- •Patients must have given written informed consent
排除标准
- •Unable to comply with the study procedure
- •Malignant tumor history within the past 5 years
- •Coexisting small cell lung cancer
- •Unqualified tissue, blood or urine samples
结局指标
主要结局
The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.
时间窗: 12 months
次要结局
- Urinary ctDNA predictive value for locoregional recurrence and distant metastasis.(3 years)
- Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis.(18 months)
- Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches.(3 years)
- The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients.(18 months)
研究者
Jun Wang
Chief of Thoracic Department
Peking University People's Hospital