AzTrials
AzTrials

CirrhosisLCN-CNCT05740358

Liver Cirrhosis Network Cohort Study

An observational study of Cirrhosis and Cirrhosis, Liver, run by Northwestern University at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cirrhosis, Cirrhosis, Liver, Cirrhosis Early
How many people
1,222 participants
Where
14 sitesUnited States
Study dates
18 Nov 2022to 24 Oct 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will include participants with cirrhosis of the liver.

Who may be able to join

  • 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 5. >5 years METAVIR stage 4 fibrosis or Ishak stage 5-6

Who cannot join

  • 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
Show all 22Show fewer
  • 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)
  • 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) > 2X upper limit of normal (ULN) within 90 days prior to consent or during Screening*
  • In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 90 days prior to consent or during Screening*
  • Indicates an exclusion criterion that may depend on laboratory results and other clinical assessments to be ordered during Screening after confirming the participant is otherwise eligible. If the test was performed as standard-of-care in the 90 days prior to consent, it does not need to be re-done for eligibility.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Cleveland Clinic

    Cleveland, Ohio, 44192

  • Duke Liver Center

    Durham, North Carolina, 27710

  • University of California San Diego NAFLD Research Center

    La Jolla, California, 92035

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • LAC + USC Medical Center

    Los Angeles, California, 90033

  • University of Miami Health System

    Miami, Florida, 33122

  • New York Presbyterian/Weill Cornell

    New York, New York, 10021

  • Columbia University Iriving School of Medicine

    New York, New York, 10031

  • Central Virginia Veterans Healthcare System

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55901

  • UCSF/Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94110

  • UCSF Medical Center

    San Francisco, California, 94143

Other trials in United States

About this 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.

Keywords
Cirrhosis, Liver, Nonalcoholic Fatty Liver Disease, NASH, Nonalcoholic steatohepatitis
Medical subject headings
Fibrosis, Liver Cirrhosis, Liver Cirrhosis, Alcoholic, Liver Cirrhosis, Biliary, Cirrhosis, Cryptogenic, Hepatitis, Autoimmune, Non-alcoholic Fatty Liver Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 years

Secondary outcomes (13)

  1. Number of decompensations

    Number of decompensations (treated as a count variable in analyses)

    Measured: 3 years

  2. All-cause mortality

    All-cause mortality (treated as time-to-event in analyses)

    Measured: 3 years

  3. Adjudicated liver-related mortality

    Adjudicated liver-related mortality (treated as time-to-event in analyses)

    Measured: 3 years

  4. All-cause hospitalizations

    All-cause hospitalizations (treated as a count variable in analyses)

    Measured: 3 years

  5. Number of liver-related hospitalizations

    Liver-related hospitalizations (treated as a count variable in analyses)

    Measured: 3 years

  6. Time to liver transplantation

    Liver transplantation (treated as time-to-event in analyses)

    Measured: 3 years

  7. Time to development of hepatocellular carcinoma (HCC)

    Development of HCC (treated as time-to-event in analyses)

    Measured: 3 years

  8. 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)

    Measured: 3 years

  9. Change in liver stiffness as measured by vibration-controlled transient elastography (VCTE)

    Liver stiffness as measured by VCTE (treated as continuous measure in analyses)

    Measured: 3 years

  10. 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)

    Measured: 3 years

  11. 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."

    Measured: 3 years

  12. 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.

    Measured: 3 years

  13. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start18 Nov 2022
  3. Primary completion24 Oct 2030 (estimated)
  4. Study completion24 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05740358
Sponsor's protocol ID
LCN Cohort Study
Other IDs
1U24DK130164-01, Pro00064389, 5U01DK130177-02, 5U01DK130197-02, 5U01DK130185-02, 5U01DK130180-02, 5U01DK130221-02, 5U01DK130134-02
Acronym
LCN-C
Status last verified
Jan 2026
First submitted
8 Feb 2023
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.

Publications

  • 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.

    PubMed 39018024

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis and Cirrhosis, Liver, run by Northwestern University at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-decompensation (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05740358, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in