Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome SignatuRes (GUDIER): an Observational Cohort Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
研究概览
简要总结
As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated.
详细描述
Patients with liver nodules will be recruited for 1 year. Peripheral blood samples of all participants will be collected after being informed about the study and potential risks. CfDNA extraction, library construction, and whole genome sequencing will be performed. A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study. Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis.
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
- •Eighteen years or elder；
- •Participants underwent enhanced MRI for the evaluation of liver nodules ≤5 cm；
- •Participants whose platelet count ≥ 50×109/L, prothrombin activity (PTA) ≥ 60%；
- •Participants who are willing and able to perform hepatectomy or tissure biopsy.
排除标准
- •Participants with different enhancement mode liver nodules that detected by enhanced MRI and without CEUS confirmation；
- •Diagnosis of malignant tumors before recruitment；
- •Anti-tumor therapy before recruitment ；
- •HIV infection；
- •Pregnancy；
- •Allogenic blood transfusion or cell therapy within 14 days before peripheral blood samples collection;
- •Participants with hepatic encephalopathy, hemangioma, ascites, gastrointestinal bleeding, jaundice, liver failure, congestive heart failure, or any other serious diseases that causing organ damage.
- •Participants with any other factors that may leading to termination of the study.
结局指标
主要结局
Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
时间窗: Enrollment of the first participant up to 18 months
Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by cfDNA signatures.
Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
时间窗: Enrollment of the first participant up to 18 months
Sensitivity is defined as the ratio of positively detected participants in all malignant nodule patients by cfDNA signatures.
次要结局
- Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis.(Through study completion，an average of 18 months)
研究者
Hong Ren
Clinical Professor
The Second Affiliated Hospital of Chongqing Medical University