Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diagnostic performance of biomarkers in research
研究概览
简要总结
Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).
详细描述
The study will enroll adult patients with known chronic liver disease, and referred to a hepatology outpatient visit for liver fibrosis assessment.
Performances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment.
Repeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care).
- •Patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights
- •Patient who is registered to the French social security program
排除标准
- •Adult patients under guardianship
- •Adult patients not being under guardianship, unable to express consent for participation
- •Pregnant women
- •Breastfeeding women
- •Patients under deprivation of liberty
- •In-hospital patients not having given their consent to participate, or admitted in emergency
- •Patients admitted in social and care centers for other reasons than those of the research
- •Patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.
结局指标
主要结局
Diagnostic performance of biomarkers in research
时间窗: At study completion, 1 year
Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to commercially available diagnostic biomarkers. Conventional diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy.
Correlation of biomarkers to existing biomarker references
时间窗: At study completion, 1 year
Biomarkers measurements performed with the device subject of the research and commercially available equipment (2 other devices used in routine care) will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.
次要结局
- Repeatability intraclass correlation coefficients (ICC)(At study completion, 1 year)
- Reproducibility intraclass correlation coefficients (ICC)(At study completion, 1 year)