Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 8
- 主要终点
- Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM
研究概览
简要总结
To determine if transient elastography (TE), when combined with ultrasound (US) pattern characterization can improve the prediction of progression to a nodular pattern on US.
To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis (CF) To prospectively assess whether TE data are associated with conventional laboratory markers of hepatic fibrosis To determine the variability of TE measurements taken at different sites in the same patient
详细描述
A noninvasive assessment of hepatic fibrosis is desperately needed to advance the care of children with CF significant liver disease and to provide for measurements during clinical trials. That global assessment might serve as both a predictor/descriptor of disease course but also as a critical biomarker for clinical research. FibroScan® measurement of liver stiffness has great potential to fill this void. The underlying hypothesis of this proposal is that elastography in addition to US can improved the prediction of the development of a nodular liver on US and development of portal hypertension over time in children and young adults with CF.
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
- 6 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants enrolled in CFLD NET PUSH study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers)
- •Entry criteria for that study were:
- •CF as determined by sweat chloride >60 meq/l
- •Pancreatic insufficiency
- •Age 3-12 years old at entry
- •For entry into the longitudinal follow up subjects were in one of two groups
- •A screening US pattern of nodular liver (CIR), heterogeneous increased echogenicity (HTG) or homogeneous increased echogenicity (HMG)
- •A screening US pattern of normal (NL) matched to a HTG subject (2 NL:1HTG) by age, center and pseudomonas status
排除标准
- •Exited from the PUSH Study
- •Unable / unwilling to sign consent
结局指标
主要结局
Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM
时间窗: Year 2
Liver stiffness" quantifies liver fibrosis and is measured in kPa (median of 10 subsequent
次要结局
- Comparison of liver stiffness and liver steatosis measurements at each time point to clinical findings of portal hypertension(Baseline, Year 1 and Year 2)
- Comparison of liver stiffness and liver steatosis measurements at each time point to grayscale ultrasound grades(Baseline, Year 1 and Year 2)
- Liver steatosis obtained via transient elastography(Baseline, Year 1, Year 2)