Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma
试验速览
- 阶段
- 不适用
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Evaluating the possibility of distinguishing between normal and lung cancer patients through the analysis of lung cancer-specific exosomal protein
研究概览
简要总结
Lung cancer is a leading cause of cancer death worldwide. Early diagnosis is linked to a better prognosis. Further, surgical resection at the early stages of non-small cell lung cancer (NSCLC) results in markedly improved survival rates. Computed tomography (CT)- or bronchoscopy-guided needle biopsies are standard definitive diagnostic procedures for lung cancer and are used to obtain tissue for pathological examination. However, these procedures are invasive, difficult to repeat, expensive, and risk exposure to radiation. Conversely, liquid biopsies, such as circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and extracellular vesicles (EVs), are simple and less invasive procedures that can be repeated more frequently than tissue biopsies.
To analyze the exosomes abundantly present in the blood and to conduct clinical studies to determine whether it is possible to diagnose lung cancer. To this end, blood samples from normal people (n = 150) and lung cancer patients (n = 320) are obtained from the Human biobank of five hospitals participating in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with primary adenocarcinoma of lung with permanent pathology of N0 or N1
- •Patients with T1mi, Tsi, T1a, T1b, T1c, T2a, and T2b stage
- •An adult of Korean nationality
- •Patients without prior chemo/radiation treatment prior to lung cancer surgery
- •Patients who have not been diagnosed with other cancers prior to lung cancer surgery
排除标准
- •Patients who do not meet the inclusion criteria
结局指标
主要结局
Evaluating the possibility of distinguishing between normal and lung cancer patients through the analysis of lung cancer-specific exosomal protein
时间窗: 3 years
Quantitative analysis using lung cancer-specific exosomal protein evaluated the possibility of distinguishing between healthy controls and lung cancer patients.
Evaluation of the distinction between healthy controls and lung cancer patients through deep-learning analysis of exosomes
时间窗: 3 years
Comparative evaluation of whether it is possible to distinguish between healthy controls and lung cancer patients through deep-learning analysis of exosomes
次要结局
- Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through deep-learning analysis of exosomes(3 years)
- Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through quantitative analysis of lung cancer specific exosomal proteins(3 years)
研究者
Hyun Koo Kim
Professor
Korea University Guro Hospital