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NCT Number: NCT07775638

Detecting Liver Fibrosis in Patients At-risk

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine study procedure

Other

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.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Torgeir Gilje Lid, Professor

CONTACT

[email protected]

+47 51513325

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Acronym: STELIR

Important dates

Study start
2026
Primary completion
2070
Study completion
2070
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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