Fatty LiverSTELIRNCT07775638
Detecting Liver Fibrosis in Patients At-risk
An observational study of Fatty Liver and NAFLD - Non-Alcoholic Fatty Liver Disease, run by Helse Stavanger HF at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease, Nash
- What is being tested?
- Routine study procedure
- How many people
- 1,200 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2026to 31 Dec 2070
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Inability to give informed consent
- Individuals outside the defined age range
- Other conditions precluding participation based on investigator assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Stavanger University Hospital
Stavanger
Forskningsposten, Stavanger University Hospital, +47 51513325, sb_hst_forskpost@ihelse.net
About this study
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.
- Conditions
- Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease, Nash, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Biomarker in Early Diagnosis, Liver Disease (Alcoholic or Not)
- Being tested
- Routine study procedure
- Keywords
- Primary care, General practice, early detection, risk stratification, case finding, Clinical prediction tools, Biomarkers, Non-invasive tests, Liver enzymes, Fibrosis assessment
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease, Liver Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine study procedureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| STELIR Cohort | Participants enrolled in the STELIR (STEatotic LIver Risk in Rogaland) cohort will be followed longitudinally as part of an observational research biobank. The cohort includes adults at increased risk of steatotic liver disease based on predefined metabolic and lifestyle risk factors.
No intervention is assigned. Participants undergo standardized clinical assessments and biological sample collection as part of routine study procedures. Receives: Other: Routine study procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startAug 2026 (estimated)
- Primary completion31 Dec 2070 (estimated)
- Study completion31 Dec 2070 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Torgeir Gilje Lid, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775638
- Sponsor's protocol ID
- 5989-5989
- Acronym
- STELIR
- Status last verified
- Aug 2026
- First submitted
- 1 May 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Liver Fibrosis in Patients At-risk
- ClinicalTrials.gov ID
- NCT07775638
- Acronym / sponsor ID
- STELIR / 5989-5989
- Conditions
- Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease, Nash, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Biomarker in Early Diagnosis, Liver Disease (Alcoholic or Not)
- Keywords
- Primary care, General practice, early detection, risk stratification, case finding, Clinical prediction tools, Biomarkers, Non-invasive tests
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Aug 2026 (estimated)
- Primary completion
- 31 Dec 2070 (estimated)
- Study completion
- 31 Dec 2070 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STELIR Cohort | – | Other: Routine study procedureParticipants enrolled in the STELIR (STEatotic LIver Risk in Rogaland) cohort will be followed longitudinally as part of an observational research biobank. The cohort includes adults at increased risk of steatotic liver disease based on predefined metabolic and lifestyle risk factors. No intervention is assigned. Participants undergo standardized clinical assessments and biological sample collection as part of routine study procedures. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Individuals outside the defined age range
- Other conditions precluding participation based on investigator assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine study procedureRoutine 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. | Other | STELIR Cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver and NAFLD - Non-Alcoholic Fatty Liver Disease, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Torgeir Gilje Lid, Professor (+47 51513325, sb_hst_forskpost@ihelse.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of non-invasive diagnostic algorithms for identification of advanced liver fibrosis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.