Biomarker in Early Diagnosis, Cirrhoses, Liver, Fatty Liver, Liver Disease (Alcoholic or Not), MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), NAFLD - Non-Alcoholic Fatty Liver Disease, Nash
Conditions
Keywords
Primary care, General practice, early detection, risk stratification, case finding, Clinical prediction tools, Biomarkers, Non-invasive tests, Liver enzymes, Fibrosis assessment
Brief summary
The project will establish a research cohort (called STELIR; STEatotisk Liver-risk In Rogaland) based on a biobank with an associated health register. The purpose is to collect, store and analyze biological material and clinical data from people at risk of steatotic liver disease (fatty liver disease). The research cohort will consist of individuals who agree to participate and will be followed over many years with planned examinations/tests at baseline, after 2 years, after 5 years and every 5 years thereafter. The STELIR cohort consists of individuals between 40 and 70 years of age who have one or more of the following risk factors: Obesity, type 2 diabetes or hazardous or harmful alcohol consumption. The biological material and clinical data collected will be stored and used for research on liver-related disease risk, diagnostics and treatment.
Interventions
OTHERRoutine study procedure
Routine study procedures include: Informed consent, medical history and clinical examination, structured questionnaires (lifestyle, alcohol use, metabolic risk factors), liver elastography, blood sample collection for clinical analyses and biobanking. Assessments are conducted at baseline, after 2 years, after 5 years, and subsequently every 5 years.
Sponsors
Helse Stavanger HF
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 40 to 70 years at the time of inclusion * At least one of the following risk factors: Overweight or obesity, type 2 diabetes mellitus, risky or harmful alcohol consumption * Ability to provide written informed consent
Exclusion criteria
* Inability to give informed consent * Individuals outside the defined age range * Other conditions precluding participation based on investigator assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of non-invasive diagnostic algorithms for identification of advanced liver fibrosis | Baseline | Area under the receiver operating characteristic curve (AUROC) of non-invasive diagnostic algorithms (combinations of clinical variables, blood-based biomarkers, and liver elastography) for identification of advanced liver fibrosis in individuals at risk of steatotic liver disease. |
Countries
Norway
Contacts
CONTACTTorgeir Gilje Lid, Professor
Outcome results
None listed