Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- measurement of fibrosis in patients with varying degrees of liver disease
研究概览
简要总结
The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.
详细描述
The Fibroscan device will determine liver stiffness as well as the amount of fat through another application on the machine called controlled attenuation parameter or Controlled Attenuation Parameters (CAP). The liver stiffness measurements are then translated into a score that tells how much liver fibrosis or fat is present. Patients identified with potential for fatty liver or specific liver-related diseases causing fibrosis would be approached for a voluntary FibroScan measurement. From these patients, the investigators will collect information related to demographics, disease history, medical comorbidities, social history, laboratory and radiologic parameters. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis
- •Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring
- •Subjects who have other known liver diseases ie: HCV
排除标准
- •Patients less than 18 years of age
- •Pregnancy
- •Patients that do not want to be contacted for consideration in future research studies.
- •Patients diagnosed with ascites or peritoneal dialysis
- •Body mass index (BMI) ≥40
结局指标
主要结局
measurement of fibrosis in patients with varying degrees of liver disease
时间窗: 10 years
single event per patient with liver disease to measure degree of fibrosis concentration
次要结局
- measurement of liver fat in patients with varying degrees of liver disease(10 years)
研究者
Ajay Chaudhuri
Principal Investigator
State University of New York at Buffalo