Detecting Liver Fibrosis in Patients At-risk

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorHelse Stavanger HF

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to give informed consent

Individuals outside the defined age range

Other conditions precluding participation based on investigator assessment

Trial population

The study population consists of adults recruited from the primary healthcare setting in Southern part of Rogaland County, Norway. Participants are identified through general practitioners and other primary care services and include community-dwelling individuals aged 40-70 years with metabolic and/or lifestyle-related risk factors for steatotic liver disease. All study visits and assessments are conducted at Stavanger University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine study procedure

    Other intervention

    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.

Treatment groups

1,200 Participants
are divided into 1 treatment group
Group A: STELIR Cohort1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of non-invasive diagnostic algorithms for identification of advanced liver fibrosis

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: