Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months (180 days), with opportunities to complete specific visit components via telehealth or remotely. Visits will include collection of questionnaire data and the in-person visits will include questionnaires, physical exams, imaging, and sample collection.
Study Type
OBSERVATIONAL
Enrollment
1,222
University of California San Diego NAFLD Research Center
La Jolla, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
LAC + USC Medical Center
Los Angeles, California, United States
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
University of Miami Health System
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Presbyterian/Weill Cornell
New York, New York, United States
Columbia University Iriving School of Medicine
New York, New York, United States
...and 4 more locations
Time-to-decompensation
Time-to-decompensation, defined as any of the following events: * Ascites: definite as determined by adjudication * Hepatic Encephalopathy (HE): definite or highly likely as determined by adjudication * Portal hypertensive upper gastrointestinal (GI) bleeding: definite as determined by adjudication
Time frame: 3 years
Number of decompensations
Number of decompensations (treated as a count variable in analyses)
Time frame: 3 years
All-cause mortality
All-cause mortality (treated as time-to-event in analyses)
Time frame: 3 years
Adjudicated liver-related mortality
Adjudicated liver-related mortality (treated as time-to-event in analyses)
Time frame: 3 years
All-cause hospitalizations
All-cause hospitalizations (treated as a count variable in analyses)
Time frame: 3 years
Number of liver-related hospitalizations
Liver-related hospitalizations (treated as a count variable in analyses)
Time frame: 3 years
Time to liver transplantation
Liver transplantation (treated as time-to-event in analyses)
Time frame: 3 years
Time to development of hepatocellular carcinoma (HCC)
Development of HCC (treated as time-to-event in analyses)
Time frame: 3 years
Time to development of portal and/or mesenteric vein thrombosis
Development of portal and/or mesenteric vein thrombosis (treated as time-to-event in analyses)
Time frame: 3 years
Change in liver stiffness as measured by vibration-controlled transient elastography (VCTE)
Liver stiffness as measured by VCTE (treated as continuous measure in analyses)
Time frame: 3 years
Degree of fibrosis as measured by fibrosis-4 index (FIB-4)
Degree of fibrosis as measured by FIB-4 (treated as continuous measure in analyses)
Time frame: 3 years
Overall physical health and overall mental health as measured by Patient Reported Outcomes Measurement Information System (PROMIS-29+2 profile v2.1)
Overall physical health and overall mental health as measured by Patient Reported Outcomes Measurement Information System (PROMIS-29+2 profile v2.1) relevant "T-scores," a continuous measure. T-scores are normalized to the population and are centered at 50 with anticipated standard deviation of 10. A higher score means better "health."
Time frame: 3 years
Change in cognitive function as measured by Stroop Test
Change in cognitive function as measured by Stroop Test (treated as continuous measure in analyses). Measured as time to complete the test. A higher score means longer time to complete, which means more impaired function. Minimum score is 0, and there is no maximum score.
Time frame: 3 years
Change in frailty as measured by the Liver Frailty Index
Change in frailty as measured by the Liver Frailty Index (treated as continuous measure in analyses). A higher score means the participant is more frail. The score is based on grip strength, number of chair stands per second, and balance time. https://liverfrailtyindex.ucsf.edu/ Maximum score of 6, and there is no minimum score.
Time frame: 3 years
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