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Observational study on liver cirrhosis risk factors

Liver Cirrhosis Network Cohort Study

Observational Northwestern University · NCT05740358

This study is trying to find out what factors increase the risk of worsening liver cirrhosis in adults by looking at around 1200 participants and gathering information through check-ups and questionnaires.

Quick facts

Study typeObservational
Enrollment1200 (estimated)
Ages18 Years and up
SexAll
SponsorNorthwestern University Academic / other
Locations14 sites (La Jolla, California and 13 other locations)
Trial IDNCT05740358 on ClinicalTrials.gov

What this trial studies

The Liver Cirrhosis Network Cohort Study is an observational study aimed at identifying risk factors and developing prediction models for the risk of decompensation in adults with liver cirrhosis. It will involve approximately 1200 participants across multiple institutions, with study visits scheduled every six months. Participants will complete questionnaires and undergo physical exams, imaging, and sample collection, with some components available via telehealth. The study seeks to enhance understanding of cirrhosis progression and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years and older who have a diagnosis of cirrhosis.

Not a fit: Patients with known hepatocellular carcinoma or cholangiocarcinoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with liver cirrhosis.

How similar studies have performed: Other studies have shown success in identifying risk factors for liver diseases, making this approach promising but not entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 5. \>5 years METAVIR stage 4 fibrosis or Ishak stage 5-6

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 (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.

Where this trial is running

La Jolla, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CirrhosisCirrhosis, LiverCirrhosis EarlyCirrhosis Due to Hepatitis BCirrhosis AdvancedCirrhosis InfectiousCirrhosis AlcoholicCirrhosis, Biliary
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.