Liver Cirrhosis Network Cohort Study
a study on Cirrhosis Fibrosis Hepatitis B Hepatitis C Primary Sclerosing Cholangitis Hepatitis A Hepatitis
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedcompletion 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:
- 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
- UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
accepting new patients
San Francisco California 94110 United States - UCSF Medical Center
accepting new patients
San Francisco California 94143 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
Frequently Asked Questions
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Submitting your contact information does not obligate you to participate in research.
Thank you!
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You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT05740358.