Liver Cirrhosis Network Cohort Study
LCN-C
14 other identifiers
observational
1,222
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2022
CompletedFirst Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 24, 2030
January 13, 2026
January 1, 2026
7.9 years
February 8, 2023
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 years
Secondary Outcomes (13)
Number of decompensations
3 years
All-cause mortality
3 years
Adjudicated liver-related mortality
3 years
All-cause hospitalizations
3 years
Number of liver-related hospitalizations
3 years
- +8 more secondary outcomes
Eligibility Criteria
The study will include participants with cirrhosis of the liver.
You may qualify if:
- 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 5. \>5 years METAVIR stage 4 fibrosis or Ishak stage 5-6
You may not qualify 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 (including trace ascites discovered at screening not requiring intervention), hepatic encephalopathy or variceal bleeding. If a patient has had a history of decompensation, they must have been off any medications to treat decompensation for at least 365 days. Refer to the MOP for clarifying details on evaluating eligibility for patients with a history of prior decompensation.
- 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)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- The Cleveland Cliniccollaborator
- Mayo Cliniccollaborator
- Columbia Universitycollaborator
- Weill Medical College of Cornell Universitycollaborator
- Duke Universitycollaborator
- University of Miamicollaborator
- University of Michigancollaborator
- University of California, San Diegocollaborator
- University of California, San Franciscocollaborator
- LAC+USC Medical Centercollaborator
- Virginia Commonwealth Universitycollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
- National Cancer Institute (NCI)collaborator
- University of Southern Californiacollaborator
- Central Virginia Veterans Healthcare Systemcollaborator
Study Sites (14)
University of California San Diego NAFLD Research Center
La Jolla, California, 92035, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
LAC + USC Medical Center
Los Angeles, California, 90033, United States
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110, United States
UCSF Medical Center
San Francisco, California, 94143, United States
University of Miami Health System
Miami, Florida, 33122, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
New York Presbyterian/Weill Cornell
New York, New York, 10021, United States
Columbia University Iriving School of Medicine
New York, New York, 10031, United States
Duke Liver Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44192, United States
Central Virginia Veterans Healthcare System
Richmond, Virginia, 23249, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (1)
Tapper EB, Goldberg D, Parikh ND, Terrault NA, Welch N, Sharpton S, Hameed B, Khalili M, Stolz A, Verna EC, Brown RS Jr, Sanyal AJ, VanWagner L, Ladner DP, Moylan CA, Diehl AM, Jones PD, Loomba R, Dasarathy S, Simonetto DA, Shah VH, Bajaj JS; LCN Study Group. The Liver Cirrhosis Network Cohort Study: Cirrhosis Definition, Study Population, and Endpoints. Am J Gastroenterol. 2025 Mar 1;120(3):570-575. doi: 10.14309/ajg.0000000000002953. Epub 2024 Jul 17.
PMID: 39018024DERIVED
Related Links
Biospecimen
Blood, urine, saliva, stool (optional)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abigail Smith
Northwestern University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 23, 2023
Study Start
November 18, 2022
Primary Completion (Estimated)
October 24, 2030
Study Completion (Estimated)
October 24, 2030
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.