Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

Summary

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.

Keywords

Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis, Biliary, Cirrhosis Cryptogenic, Cirrhosis Due to Hepatitis C, Cirrhosis Due to Primary Sclerosing Cholangitis, Liver, Nonalcoholic Fatty Liver Disease, NASH, Nonalcoholic steatohepatitis, Hepatitis A, Hepatitis C, Hepatitis B, Hepatitis, Liver Cirrhosis, Cholangitis, Sclerosing Cholangitis, Biliary Liver Cirrhosis, Alcoholic Liver Cirrhosis, Fibrosis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years
  • Willing to provide samples at baseline
  • Cirrhosis

    Where Cirrhosis is defined as:

  • At least one liver biopsy within 5 years prior to consent showing either: a) Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis OR
  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego NAFLD Research Center accepting new patients
    La Jolla California 92035 United States
  • Keck Medical Center of USC accepting new patients
    Los Angeles California 90033 United States
  • LAC + USC Medical Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
Links
Information about the study
ID
NCT05740358
Study Type
Observational
Participants
Expecting 1200 study participants
Last Updated