ACTIVE_NOT_RECRUITING

Liver Cirrhosis Network Cohort Study

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Conditions

CirrhosisCirrhosis, LiverCirrhosis EarlyCirrhosis Due to Hepatitis BCirrhosis AdvancedCirrhosis InfectiousCirrhosis AlcoholicCirrhosis, BiliaryCirrhosis CryptogenicCirrhosis Due to Hepatitis CCirrhosis Due to Primary Sclerosing CholangitisAutoimmune HepatitisLiverNonalcoholic Fatty Liver DiseaseNASHNonalcoholic steatohepatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Liver Cirrhosis Network Cohort Study

Quick Facts

Study Start:2022-11-18
Study Completion:2030-10-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05740358

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Willing to provide samples at baseline
  3. * Cirrhosis
  4. 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
  5. 2. At least 2 of the following:
  1. * Known and documented prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma
  2. * Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence
  3. * Known prior solid organ transplant or bone marrow transplant
  4. * Current participation in active medication treatment trials at the time of consent for LCN Cohort Study
  5. * Prisoners or individuals with more than 180 days incarceration pending due to difficulty with visits
  6. * Bariatric surgery in the last 180 days prior to consent
  7. * Known history of fontan procedure-associated liver disease (FALD)
  8. * 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
  9. * 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)
  10. * Documented history of acute alcohol-associated hepatitis (according to NIAAA criteria as described in the MOP) in the 180 days prior to consent
  11. * Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
  12. * In patients with primary sclerosing cholangitis (PSC): Current active cholangitis with 90 days prior to consent
  13. * Documented cardiac cirrhosis
  14. * 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.
  15. * 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)
  16. * Current model for end-stage liver disease (MELD-Na) cut off ≥ 15\*
  17. * Current Child-Turcotte-Pugh (CTP) B or C\*
  18. * Current known Hepatitis C Virus (HCV) without sustained virologic response (SVR)
  19. * Current known quantifiable Hepatitis B Virus (HBV) viral DNA on therapy with ongoing adherence on suppressive therapy\*
  20. * In patients with autoimmune hepatitis: serum aspartate aminotransferase (AST) \> 2X upper limit of normal (ULN) within 90 days prior to consent or during Screening\*
  21. * In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 90 days prior to consent or during Screening\*
  22. * 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.

Contacts and Locations

Principal Investigator

Abigail Smith
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Northwestern University

  • Abigail Smith, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-18
Study Completion Date2030-10-24

Study Record Updates

Study Start Date2022-11-18
Study Completion Date2030-10-24

Terms related to this study

Keywords Provided by Researchers

  • Cirrhosis
  • Liver
  • Nonalcoholic Fatty Liver Disease
  • NASH
  • Nonalcoholic steatohepatitis

Additional Relevant MeSH Terms

  • 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
  • Autoimmune Hepatitis