Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1222 participants
OBSERVATIONAL
2022-11-18
2030-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Columbia University
OTHER
Weill Medical College of Cornell University
OTHER
Duke University
OTHER
Mayo Clinic
OTHER
University of Miami
OTHER
University of Michigan
OTHER
University of California, San Diego
OTHER
University of California, San Francisco
OTHER
LAC+USC Medical Center
OTHER
Virginia Commonwealth University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Central Virginia Veterans Healthcare System
UNKNOWN
Northwestern University
OTHER
Responsible Party
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Abigail Smith
Associate Professor
Principal Investigators
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Abigail Smith
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of California San Diego NAFLD Research Center
La Jolla, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
LAC + USC Medical Center
Los Angeles, California, United States
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
University of Miami Health System
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Presbyterian/Weill Cornell
New York, New York, United States
Columbia University Iriving School of Medicine
New York, New York, United States
Duke Liver Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Central Virginia Veterans Healthcare System
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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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.
Related Links
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Information about the study
Other Identifiers
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Pro00064389
Identifier Type: OTHER
Identifier Source: secondary_id
LCN Cohort Study
Identifier Type: -
Identifier Source: org_study_id
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