Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05335603

Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis

Led by University of Copenhagen · Updated on 2022-04-19

335

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Copenhagen

Lead Sponsor

H

Hvidovre University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating patients with chronic liver diseases linked to hepatic steatosis, a condition where fat accumulation in the liver may cause inflammation and scarring. This condition can lead to serious liver problems such as cirrhosis, liver failure, and death. The study aims to better understand the underlying mechanisms of these diseases and to identify specific diagnostic markers and potential future treatments by examining tissue-level characteristics. This observational study involves collecting detailed biological samples and data from adults with various chronic liver diseases, including autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis, alpha-1-antitrypsin deficiency, and others. The study does not involve any drug or device interventions but focuses on in-depth phenotyping and metabolic assessments at multiple time points. Participants will be observed and evaluated over a period of up to 10 years. Researchers will collect plasma samples at several intervals and aim to identify diagnostic classifiers to distinguish between different chronic liver diseases. The study includes regular assessments and long-term monitoring to gather comprehensive data on metabolic disturbances and disease characteristics. Participation involves informed consent and adherence to scheduled evaluations without treatment administration.

CONDITIONS

Brief Title

An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients or healthy control participants aged 18 or older who can give informed consent
  • Suspected liver disease including non-alcoholic steatohepatitis
  • Alcoholic steatohepatitis
  • Autoimmune hepatitis
  • Primary biliary cholangitis
  • Primary sclerosing cholangitis
  • Inflammatory bowel disease
  • Polycystic ovary syndrome
  • Hereditary haemochromatosis
  • Chronic pancreatitis
  • Cystic fibrosis
  • Alpha-1 antitrypsin deficiency
Not Eligible

You will not qualify if you...

  • Patients with malignant diseases
  • Patients with viral hepatitis
  • Patients with human immunodeficiency virus
  • Patients with contraindications to liver biopsy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Sample Collection

Duration - Single day

Participants provide plasma samples at several time points to identify metabolic disturbances within chronic liver diseases.

1 visit (in-person) with multiple blood draws at 0, 15, 30, 45, 60, 90, and 120 minutes

Long-term Monitoring

Duration - Up to 10 years

Participants are observed over an extended period to identify and validate diagnostic classifiers for chronic liver diseases.

Trial Site Locations

Total: 1 location

1

Hvidovre University Hospital

Hvidovre, Denmark, 2650

Actively Recruiting

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Research Team

A

Anne-Sofie H Jensen, MD

L

Lise L Gluud, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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