The Training and Validation Study: Development of a Red Blood Cells Based Blood Test for Early Detection of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 852
- 主要终点
- Specificity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
研究概览
简要总结
This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.
详细描述
This is a prospective, multi-center, observational, cohort study and seeks to enroll 852 participants with pulmonary nodules smaller than 3 cm in diameter from 4 hospitals in China.
Each participant pulmonary nodule is ≤30mm as assessed by CT scanning, nodule is suspected to be malignant, and plan to use biopsy or surgery for diagnosis or treatment within 60 days.Their blood samples, CT scan data, and clinical data will be collected at each visit and tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.
Each subject will analysis DNA and RNA methylation in nucleic acids extracted from mature red blood cells isolated from peripheral blood by next-generation sequencing (NGS) . A proprietary algorithm will be used to identify the modification sites and pattern for differentiating the benign and malignant pulmonary nodules. Sensitivity and specificity of the different methylation panels will be to evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary nodule is ≤3cm;
- •Subjects suspected of lung cancer;
- •Diagnosis or treatment by biopsy or surgery within 60 days;
- •Signed informed consent.
排除标准
- •History of malignant tumors;
- •Received anti-tumor therapy;
- •Can't collect the histopathological results or the pathological results are metastatic cancer;
- •Can't obtain detection information of red blood cells;
- •Pregnancy or lactating female；
- •Other situations not suitable for the study.
结局指标
主要结局
Specificity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
时间窗: 3 years
Positive predictive value (PPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
时间窗: 3 years
Sensitivity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
时间窗: 3 years
Negative predictive value (NPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
时间窗: 3 years
次要结局
- Area under curve (AUC) of receiver operating characteristic curve (ROC) in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.(3 years)
- Sensitivity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.(3 years)
- Sensitivity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.(3 years)
- Specificity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.(3 years)
- Specificity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.(3 years)