Clinical Trials on Detection of Lung Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of lung cancer
研究概览
简要总结
A central challenge in the fight against lung cancers is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast and lung cancers, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of lung cancer is urgently needed.
The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in lung cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Histological confirmed lung cancer
排除标准
- •Pregnant women
- •Minors (subjects less than 18 years of age)
- •Prisoners
- •Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
- •Patients having other than one cancer
- •Subjects unable to consent for themselves
结局指标
主要结局
DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of lung cancer
时间窗: 6 months to 1 year
The outcome is the methylation score, which combines the weighted methylation values of four CpGs. A threshold methylation score that differentiates between control and cancer individuals will be calculated from the training set of 100 patients. The model will be provided to the researchers: Methylation score=CG1\*b1+CG2\*b2+ CG3\*b3+ CG4\*b4 + e CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and "e" equals the intercept. Investigators will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. Investigators will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as lung cancer or not.
次要结局
未报告次要终点