Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Noninvasive assisted diagnosis of benign and malignant pulmonary nodules
研究概览
简要总结
Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.
详细描述
In this study, the investigators sought to explore sensitive and specific methylation biomarkers that are highly prevalent in lung cancer. It is the first time to perform screening assay on healthy, lung nodule, and lung cancer tissues to identify preliminary set of highly prevalent methylation markers, and then refined these markers by removing regions were unstable in matched plasma samples. Next, investigators interrogated significant methylation marker regions enriched in lung nodules of training sample set to buildup a non-invasive biomarker classification model to discriminate cancerous nodules from benign lesions. Eventually, the model in patient lung nodule samples were validated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old or above with pulmonary nodule(s) found by LDCT, mean diameter below 30mm.
- •The nodule lesion is peripheral, no signs of lymphatic infiltration or distal metastasis.
- •Fit and consent to surgical resection.
- •Agree to participate in this study and sign informed consents.
排除标准
- •Fail to understand or agree to sign informed consent.
- •Patients who did not follow the test plan for timely blood collection or did not cooperate with the study follow-up work.
- •Patients with previous history of cancer and/or cancer treatment such as surgery, radiotherapy, chemotherapy or targeted therapy.
- •Failing to meet the requirements for blood sampling.
结局指标
主要结局
Noninvasive assisted diagnosis of benign and malignant pulmonary nodules
时间窗: 1 year
The biomarker classification model can be used to differentiate patients, who had positive LDCT results, with benign or malignant lung nodules.
次要结局
未报告次要终点
研究者
Lu Shun
Principle Investigator
Shanghai Chest Hospital