Clinical trial NCT05335603: An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Official title: Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Liver Disease
Keywords: non-alcoholic fatty liver disease
non-alcoholic steatohepatitis
steatosis
autoimmune hepatitis
primary biliary cholangitis
primary sclerosing cholangitis
haemochromatosis
alfa-1-antitrypsin deficiency
chronic pancreatitis
chronic liver disease
inflammatory bowel disease
OMICS
Mass spectrometry
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2022-04-19
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potentially eligible patients will be identified and recruited among those referred with suspected liver disease at the outpatient clinic at the Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark. Healthy control participants will be recruited through advertisements at forsoegsperson.dk and posters. Posters will be mounted in neutral places at Copenhagen University Hospital Hvidovre and at neutral places at the Panum Institute. Copenhagen University Hospital Hvidovre is a large regional hospital with more than 3500 employees and the Panum Institute is a large building complex in Copenhagen, Denmark that houses the Faculty of Health and Medical Sciences.

Brief summary: Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.


Eligibility criteria: Inclusion Criteria:

* Adult patients/healthy control participants (age 18 or above) who can give their informed consent
* Suspected liver disease:
* 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

Exclusion Criteria:

Patients with:

* malignant diseases
* viral hepatitis
* human immunodeficiency virus
* contraindications to liver biopsy

Primary outcomes:
measure: Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.
timeFrame: 10 years
Secondary outcomes:
measure: To identify any metabolic disturbances within chronic liver diseases
timeFrame: Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.
Other outcomes:
measure: Fibrosis stage of the liver
timeFrame: 10 years
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Lise L Gluud, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: NNF Center for Protein Research
name: Nicolai J Wewer Albrechtsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: