Cirrhosis Clinical Trial
— LCN-COfficial title:
Liver Cirrhosis Network Cohort Study
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.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | September 1, 2028 |
Est. primary completion date | September 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Willing to provide samples at baseline - Cirrhosis Where Cirrhosis is defined as: 1. At least one liver biopsy within 5 years prior to consent showing either: a) Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis OR 2. At least 2 of the following: 1. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past year 2. Liver stiffness: VCTE within one year prior to consent or during Screening =12.5 kPa or MRE within one year prior to consent or during Screening =5 kPa 3. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening 4. Either: FIB-4>2.67 or platelets <150/mL within 6 months prior to consent or during Screening Exclusion Criteria: - Known and documented prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma - Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence - Known prior solid organ transplant or bone marrow transplant - Current participation in active medication treatment trials at the time of consent for LCN Cohort Study - Prisoners or individuals with more than 180 days incarceration pending due to difficulty with visits - Bariatric surgery in the last 180 days prior to consent - Known history of fontan procedure-associated liver disease (FALD) - Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with or prevent follow-up per protocol - Current liver-unrelated end-stage organ failures (Dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen, current known active malignancy besides non-melanomatous skin cancer or carcinoma in situ) - Documented history of acute alcohol-associated hepatitis (according to NIAAA criteria as described in the MOP) in the 180 days prior to consent - Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis) - In patients with primary sclerosing cholangitis (PSC): Current active cholangitis with 90 days prior to consent - Documented cardiac cirrhosis - Known recent (within the last 365 days) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding - Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples) - Current model for end-stage liver disease (MELD-Na) cut off = 15 - Current Child-Turcotte-Pugh (CTP) B or C - Current known Hepatitis C Virus (HCV) without sustained virologic response (SVR) - Current known quantifiable Hepatitis B Virus (HBV) viral DNA on therapy with ongoing adherence on suppressive therapy - In patients with autoimmune hepatitis: serum aspartate aminotransferase (AST) > 2 times upper limit of normal (ULN) within 60 days prior to consent or during Screening - In patients living with HIV: cluster of differentiation 4 (CD4) + T cell count less than 100 cells/mm3 within 60 days prior to consent or during Screening |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Duke Liver Center | Durham | North Carolina |
United States | 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 | University of Miami Health System | Miami | Florida |
United States | Columbia University Iriving School of Medicine | New York | New York |
United States | New York Presbyterian/Weill Cornell | New York | New York |
United States | Central Virginia Veterans Healthcare System | Richmond | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | UCSF Medical Center | San Francisco | California |
United States | UCSF/Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Central Virginia Veterans Healthcare System, Columbia University, Duke University, LAC+USC Medical Center, Mayo Clinic, National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute on Alcohol Abuse and Alcoholism (NIAAA), The Cleveland Clinic, University of California, San Diego, University of California, San Francisco, University of Miami, University of Michigan, University of Southern California, Virginia Commonwealth University, Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time-to-decompensation | Time-to-decompensation, defined as any of the following events:
Ascites: Grade 2 or 3 Hepatic Encephalopathy (HE) (i.e., an episode of overt HE) Portal hypertensive upper gastrointestinal (GI) bleeding |
3 years | |
Secondary | Number of decompensations | Number of decompensations (treated as a count variable in analyses) | 3 years | |
Secondary | All-cause mortality | All-cause mortality (treated as time-to-event in analyses) | 3 years | |
Secondary | Adjudicated liver-related mortality (treated as time-to-event in analyses) | Adjudicated liver-related mortality (treated as time-to-event in analyses) | 3 years | |
Secondary | All-cause hospitalizations | All-cause hospitalizations (treated as a count variable in analyses) | 3 years | |
Secondary | Number of liver-related hospitalizations | Liver-related hospitalizations (treated as a count variable in analyses) | 3 years | |
Secondary | Time to liver transplantation | Liver transplantation (treated as time-to-event in analyses) | 3 years | |
Secondary | Time to development of hepatocellular carcinoma (HCC) | Development of HCC (treated as time-to-event in analyses) | 3 years | |
Secondary | 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) | 3 years | |
Secondary | Major adverse cardiac events (MACE) | MACE (treated as time-to-event in analyses) | 3 years | |
Secondary | Change in liver stiffness as measured by vibration-controlled transient elastography (VCTE) | Liver stiffness as measured by VCTE (treated as continuous measure in analyses) | 3 years | |
Secondary | 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) | 3 years | |
Secondary | 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." | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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. | 3 years |
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