NAFLDFLD_FU_HUSNCT05971082
Risk Factors for Advanced Fibrosis Among FLD Patients
An observational study of NAFLD and Liver Cirrhosis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- NAFLD, Liver Cirrhosis, Diabetes Mellitus, Type 2
- What is being tested?
- Follow-up
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- 24 Aug 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. See eligibility criteria for details.
Who may be able to join
- Liver imaging results in the Helsinki University Hospital datalake 2010-2018 and a finding of fatty liver disease (without liver cirrhosis)
- Age 25-70 years(20-60 yrs at the time of the index imaging (2010-2018)
- Biobank consent with the Helsinki Biobank to be contacted for possible studies
Who cannot join
- Liver cirrhosis at index imaging date; pregnancy; active treatment for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Advanced Fibrosis Among Fatty Liver Disease Patients Identified Through Pharese-screening of Miaging Reports
The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.
To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. Within the data lake of Helsinki University Hospital, they identified a large number of individuals with or without FLD. The investigators will now randomly invite 1000-1500 individuals with FLD to a follow-up study including investigation of metabolism and progression of liver disease (elastography, blood tests) as well as gathering life-style information. Register data on previous diagnoses and medication will be used to evaluate cardiovascular disease.
Read the detailed description
The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.
To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. This allows them to study also individuals who have had abdominal imaging for any reason (usually not for suspected liver disease). Within the data lake of Helsinki University Hospital, the investigators identified 61,271 individuals with FLD and 155,521 without. The investigators have obtained national register data on their diagnosed diseases and medication.
The investigators will now invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. Progression of liver disease will be studied by elastography, measurement of fat content and a blood sample for fibrosis markes (ELF score). The participants' metabolism will be evaluated with several laboraroty tests and an i.v. glucagon tolerance test and amino acid response. Questionnaires will be used to obtain life-style information.
- Conditions
- NAFLD, Liver Cirrhosis, Diabetes Mellitus, Type 2
- Being tested
- Follow-up
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Follow-up study of progression/remission of liver disease
| Study group | Role | What they receive |
|---|---|---|
| Recall study | Recruited individuals aged 20-60 at index imaging date invited for follow-up with liver elastography and fat prosentage measurement Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of liver disease
Proportion of participants who have developed liver fibrosis or steatosis since the index date (in 2010-2018)
Measured: 5-15 years
remission of fatty liver disease
Proportion of participants with remission of fatty liver (= no detectable liver fat) since the index date (in 2010-2018)
Measured: 5-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start24 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Tiinamaija Tuomi, Helsinki University Central Hospital
- Investigators
- Tiinamaija Tuomi, MD, PhD, Study director, Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971082
- Sponsor's protocol ID
- FLD_FU_HUS
- Acronym
- FLD_FU_HUS
- Status last verified
- Oct 2023
- First submitted
- 29 Jun 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be requested from the HUS University Hospital
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Advanced Fibrosis Among Fatty Liver Disease Patients Identified Through Pharese-screening of Miaging Reports
- ClinicalTrials.gov ID
- NCT05971082
- Acronym / sponsor ID
- FLD_FU_HUS / FLD_FU_HUS
- Conditions
- NAFLD, Liver Cirrhosis, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Aug 2023 (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 investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.
To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. Within the data lake of Helsinki University Hospital, they identified a large number of individuals with or without FLD. The investigators will now randomly invite 1000-1500 individuals with FLD to a follow-up study including investigation of metabolism and progression of liver disease (elastography, blood tests) as well as gathering life-style information. Register data on previous diagnoses and medication will be used to evaluate cardiovascular disease.
Detailed description
The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.
To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. This allows them to study also individuals who have had abdominal imaging for any reason (usually not for suspected liver disease). Within the data lake of Helsinki University Hospital, the investigators identified 61,271 individuals with FLD and 155,521 without. The investigators have obtained national register data on their diagnosed diseases and medication.
The investigators will now invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. Progression of liver disease will be studied by elastography, measurement of fat content and a blood sample for fibrosis markes (ELF score). The participants' metabolism will be evaluated with several laboraroty tests and an i.v. glucagon tolerance test and amino acid response. Questionnaires will be used to obtain life-style information.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recall study | – | Other: Follow-upRecruited individuals aged 20-60 at index imaging date invited for follow-up with liver elastography and fat prosentage measurement |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. See eligibility criteria for details.
Key inclusion criteria (3 listed)
- Liver imaging results in the Helsinki University Hospital datalake 2010-2018 and a finding of fatty liver disease (without liver cirrhosis)
- Age 25-70 years(20-60 yrs at the time of the index imaging (2010-2018)
- Biobank consent with the Helsinki Biobank to be contacted for possible studies
Key exclusion criteria (1 listed)
- Liver cirrhosis at index imaging date; pregnancy; active treatment for cancer
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 |
|---|---|---|
| Follow-upFollow-up study of progression/remission of liver disease | Other | Recall study |
Primary outcome
Progression of liver disease
Time frame: 5-15 years
Proportion of participants who have developed liver fibrosis or steatosis since the index date (in 2010-2018)
remission of fatty liver disease
Time frame: 5-15 years
Proportion of participants with remission of fatty liver (= no detectable liver fat) since the index date (in 2010-2018)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No. Data can be requested from the HUS University Hospital
Related trials for NAFLD
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RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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. This study is not recruiting at the moment.
Tiinamaija Tuomi, MD, PhD study director
Chief Physician
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 NAFLD and Liver Cirrhosis, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of liver disease (time frame: 5-15 years). The study lists 2 primary outcomes in all. 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 17 Oct 2023.