Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- measurement of fibrosis in patients with varying degrees of liver disease
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
measurement of fibrosis in patients with varying degrees of liver disease
Time Frame: 10 years
single event per patient with liver disease to measure degree of fibrosis concentration
Secondary Outcomes
- measurement of liver fat in patients with varying degrees of liver disease(10 years)
Investigators
Ajay Chaudhuri
Principal Investigator
State University of New York at Buffalo