Liver Cirrhosis Network Cohort Study

Status: Recruiting
Location: See all (14) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California San Diego NAFLD Research Center
RECRUITING
La Jolla
Keck Medical Center of USC
RECRUITING
Los Angeles
LAC + USC Medical Center
RECRUITING
Los Angeles
UCSF Medical Center
RECRUITING
San Francisco
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
RECRUITING
San Francisco
Florida
University of Miami Health System
RECRUITING
Miami
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Duke Liver Center
RECRUITING
Durham
New York
Columbia University Iriving School of Medicine
RECRUITING
New York
New York Presbyterian/Weill Cornell
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Virginia
Central Virginia Veterans Healthcare System
RECRUITING
Richmond
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Crystal K Santillanes, MS
lcn@northwestern.edu
312-503-5536
Time Frame
Start Date: 2022-11-18
Estimated Completion Date: 2028-07-25
Participants
Target number of participants: 1200
Sponsors
Collaborators: Mayo Clinic, Weill Medical College of Cornell University, University of Southern California, University of California, San Diego, University of Miami, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Michigan, The Cleveland Clinic, LAC+USC Medical Center, Duke University, Central Virginia Veterans Healthcare System, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Columbia University, Virginia Commonwealth University, National Cancer Institute (NCI), University of California, San Francisco
Leads: Northwestern University

This content was sourced from clinicaltrials.gov