Non-alcoholic Fatty Liver Disease (NAFLD)SOPRANONCT05699018
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
A study testing eLIFT in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Alcoholic Liver Disease (ALD), run by University Hospital, Angers at 13 sites in France.
Trial summary
The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD), Alcoholic Liver Disease (ALD), Liver Fibrosis
- What is being tested?
- eLIFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,788 participants
- Where
- 13 sitesFrance
- Study dates
- 13 Mar 2023to 12 Sep 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NAFLD and/or ALD patient defined by at least 1 of the following criteria:
- Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women)
- Type 2 diabetes
- at least 2 metabolic factors among BMI higher than or equal to 25 kg / m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory)
- Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)
- Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria:
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- Excessive alcohol consumption: >210 g/week in men or >140 g/week in women,
- AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
- AND with the following stratification:
- 30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments)
- Patient's agreement to have a blood sample collected in a local laboratory participating in the study
- Subjects covered by or having the rights to medical care assurance
- Written informed consent obtained from subject
Who cannot join
- Already ongoing specialized follow-up for a chronic liver disease
- Altered health status with poor short-term prognosis, not compatible with a screening procedure
- Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- Acute infection
- Pregnancy, breastfeeding
- Persons in detention by judicial or administrative decision
Show all 9Show fewer
- Person admitted to a health or social establishment for purposes other than research
- Person subject to a legal protection measure
- Person unable to express consent
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 1 recruiting
- Completed
ANGERS
Angers, 49000
- Active, not recruiting
CHU Angers
Angers, 49000
- Recruiting
BAUGE
Baugé-en-Anjou, 49150
Laurent CASTRIQUE, MD, 02 41 89 72 72 ext. +33, laurentcastrique@orange.fr
- Completed
BECON
Bécon-les-Granits, 49370
- Completed
Chalonnes
Chalonnes-sur-Loire, 49290
- Completed
COMBOURG
Combourg, 35270
- Completed
LIFFRE
Liffré, 35340
- Completed
Montreuil
Montreuil-Bellay, 49260
- Completed
RENNES - Armagnac, Churchill
Rennes, 35000
- Completed
RENNES - Kennedy
Rennes, 35000
- Active, not recruiting
CHU Rennes
Rennes, 35033
- Completed
SEGRE
Segré, 49500
- Completed
Val Couesnon
Val-couesnon, 35560
About this study
The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.
Read the detailed description
Chronic liver diseases (CLD) are responsible for 17 000 deaths each year in France (cirrhosis: 8 000, liver cancer: 9 000). Non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD) are the two main causes of CLD in France, affecting respectively 25% and 12% of the adult general population. A subset of these patients develops advanced liver fibrosis (ALF), which requires referral to the specialist for specific evaluation and management to avoid the occurrence of cirrhosis and its life-threatening complications. General practitioners (GPs) are the first-line physicians in front of the large population of NAFLD and/or ALD patients. It is very difficult for GPs to identify the patients who develop ALF and require referral to the specialist, as their physical examination, usual biology and ultrasonography remain normal.
The non-invasive diagnosis of liver fibrosis is now available with elastography devices and blood tests. Elastography is a very accurate method but it is available only in few specialised centers. Specialised blood tests are available to all physicians, but they are quite expensive and not reimbursed with therefore limited use in clinical practice. Consequently, liver fibrosis remains unevaluated in most patients with NAFLD and/or ALD, which explains why a lot are too late diagnosed at the stage of cirrhosis complications with poor short-term survival.
The eLIFT isa new blood fibrosis test specifically dedicated for GPs with simple parameters and easy "by head" calculation. The simple eLIFT was compared with the specialised blood test FibroMeter for the diagnosis of ALF in an cohort of 1024 biopsy-proven NAFLD and/or ALD patients. eLIFT was little less accurate than FibroMeter (AUROC: 0.78 vs 0.81). Using the recommended cut-offs (eLIFT ≥8, FibroMeter ≥0.46), eLIFT was more sensitive than FibroMeter (86% vs 77%), whereas FibroMeter was highly more specific (71% vs 51%). These results position eLIFT and FibroMeter as interesting tools for the screening of ALF in large populations.
As the preliminary results come from very selected patients, i.e. patients from tertiary centers who underwent a liver biopsy, it's necessary nox to evaluate in the real condition of primary care setting whether the use of eLIFT or FibroMeter will help GPs to screen ALF in their asymptomatic NAFLD and ALD patients.
- Being tested
- eLIFT
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Alcoholic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eLIFTDiagnostic test
Diagnostic procedure: elastography devices, blood tests (e-LIFT + Fibrometer), liver biopsy if necessary (elastometry ≥ 8 kPa and < 15 kPa)
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test: e-LIFT | Other | only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference Receives: Diagnostic Test: eLIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the eLIFT test for advanced liver fibrosis
Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test
Measured: 1 day
Sensitivity of the Fibrometer test for advanced liver fibrosis
Rate of patients with advanced liver fibrosis correctly identified by the Fibrometer test
Measured: 1 day
Secondary outcomes (14)
rate of patients referred to the specialist following the screening procedure, with eLIFT test
Rate of patients with positive screening test (eLIFT ≥8)
Measured: 1 day
rate of patients referred to the specialist following the screening procedure, with FibroMeter test
Rate of patients with positive screening test (FibroMeter ≥0.46)
Measured: 1 day
Rate of "unnecessary referrals" to the specialist with eLIFT test
Rate of patients with positive screening test (eLIFT ≥8) but without final diagnosis of ALF
Measured: 1 month
Rate of "unnecessary referrals" to the specialist with Fibrometer test
Rate of patients with positive screening test (FibroMeter ≥0.46) but without final diagnosis of ALF
Measured: 1 month
Number of hepatocellular carcinoma adetected following the screening procedure, with comparison between eLIFT and FibroMeter strategies
Number of patients with hepatocellular carcinoma (diagnosed on MRI by the recommended radiological criteria: hyperenhancement on the arterial phase and washout on the portal venous phase, or by liver biopsy);
Measured: 1 month
Number of gastroesophageal varices at risk of bleeding detected following the screening procedure, with comparison between eLIFT and FibroMeter strategies
Number of patients with gastroesophageal varices at risk of bleeding (diagnosed by upper-gastrointestinal endoscopy: medium-large varices or small varices with red wall marks)
Measured: 1 month
directs costs by type of disease such as ALF, hepatocellular carcinoma, gastroesophageal varices at risk of bleeding with comparison between eLIFT and FibroMeter strategies
Mean direct cost per patient; mean direct cost generated to detect one patient with ALF, one patient with hepatocellular carcinoma, one patient with gastroesophageal varices at risk of bleeding
Measured: 1 month
eLIFT and FibroMeter screening procedures as a function of the cause of the underlying liver disease (NAFLD, ALD, or mixed NAFLD+ALD)
Rate of patient with ALF, positive screening test, hepatocellular carcinoma, gastroesophageal varices at risk of bleeding, and mean cost, with comparison between NAFLD, ALD, and mixed NAFLD+ALD subgroups
Measured: 1 month
the accuracy of a sequential strategy using eLIFT as first-line test and FibroMeter as second-line test
Rate of patients with ALF diagnosed by a stepwise algorithm using eLIFT ≥8 then, if positive, FibroMeter ≥0.46
Measured: 1 day
patient adherence to the screening of advanced liver fibrosis
Rate of patients included in the study who did not achieve the required screening procedures
Measured: 1 month
most relevant risk factor of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care
Risk factors among clinical characteristics, alcohol consumption, metabolic parameters independently associated with ALF diagnosis
Measured: 1 day
specialized blood test ELF for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers
Same endpoints than primary and secondaries 1 to 11, but using the recommended 9.8 threshold for ELF
Measured: 1 day
Camden and Islington pathway (FIB4 then ELF) for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers,
Same endpoints than primary and secondaries 1 to 11, but using using the Camden and Islington pathway
Measured: 1 day
Camden and Islington pathway , with comparison of sequential strategy eLIFT then FibroMeter
Same endpoints than primary and secondaries 1 to 11, but using using the Camden and Islington pathway
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start13 Mar 2023
- Primary completion12 Jun 2026
- Study completion12 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The SOPRANO study is a multicenter prospective comparative diagnostic study . Evaluation of a simple blood test (e-LIFT) for the diagnosis of advanced liver fibrosis. Reference for advanced liver diagnosis : composite criteria : * Elastometry between 8 kPa and 14.9 kPa and histologic evaluation of fibrosis ≥ F3 (NASH CRN ) OR * Elastometry ≥ 15 kPa
- Masking
- None (open label)
- Enrolment
- 1,788 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699018
- Sponsor's protocol ID
- 2022-A02148-35
- Acronym
- SOPRANO
- Status last verified
- Jun 2026
- First submitted
- 28 Dec 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
- ClinicalTrials.gov ID
- NCT05699018
- Acronym / sponsor ID
- SOPRANO / 2022-A02148-35
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,788 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Sep 2026 (estimated)
- First posted
- 26 Jan 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 primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.
Detailed description
Chronic liver diseases (CLD) are responsible for 17 000 deaths each year in France (cirrhosis: 8 000, liver cancer: 9 000). Non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD) are the two main causes of CLD in France, affecting respectively 25% and 12% of the adult general population. A subset of these patients develops advanced liver fibrosis (ALF), which requires referral to the specialist for specific evaluation and management to avoid the occurrence of cirrhosis and its life-threatening complications. General practitioners (GPs) are the first-line physicians in front of the large population of NAFLD and/or ALD patients. It is very difficult for GPs to identify the patients who develop ALF and require referral to the specialist, as their physical examination, usual biology and ultrasonography remain normal.
The non-invasive diagnosis of liver fibrosis is now available with elastography devices and blood tests. Elastography is a very accurate method but it is available only in few specialised centers. Specialised blood tests are available to all physicians, but they are quite expensive and not reimbursed with therefore limited use in clinical practice. Consequently, liver fibrosis remains unevaluated in most patients with NAFLD and/or ALD, which explains why a lot are too late diagnosed at the stage of cirrhosis complications with poor short-term survival.
The eLIFT isa new blood fibrosis test specifically dedicated for GPs with simple parameters and easy "by head" calculation. The simple eLIFT was compared with the specialised blood test FibroMeter for the diagnosis of ALF in an cohort of 1024 biopsy-proven NAFLD and/or ALD patients. eLIFT was little less accurate than FibroMeter (AUROC: 0.78 vs 0.81). Using the recommended cut-offs (eLIFT ≥8, FibroMeter ≥0.46), eLIFT was more sensitive than FibroMeter (86% vs 77%), whereas FibroMeter was highly more specific (71% vs 51%). These results position eLIFT and FibroMeter as interesting tools for the screening of ALF in large populations.
As the preliminary results come from very selected patients, i.e. patients from tertiary centers who underwent a liver biopsy, it's necessary nox to evaluate in the real condition of primary care setting whether the use of eLIFT or FibroMeter will help GPs to screen ALF in their asymptomatic NAFLD and ALD patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The SOPRANO study is a multicenter prospective comparative diagnostic study . Evaluation of a simple blood test (e-LIFT) for the diagnosis of advanced liver fibrosis. Reference for advanced liver diagnosis : composite criteria : * Elastometry between 8 kPa and 14.9 kPa and histologic evaluation of fibrosis ≥ F3 (NASH CRN ) OR * Elastometry ≥ 15 kPa
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test: e-LIFT | Other | Diagnostic Test: eLIFTonly one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- NAFLD and/or ALD patient defined by at least 1 of the following criteria:
- Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria:
- Excessive alcohol consumption: >210 g/week in men or >140 g/week in women,
- AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
- AND with the following stratification:
Key exclusion criteria (9 listed)
- Already ongoing specialized follow-up for a chronic liver disease
- Altered health status with poor short-term prognosis, not compatible with a screening procedure
- Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- Acute infection
- Pregnancy, breastfeeding
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 |
|---|---|---|
| eLIFTDiagnostic procedure: elastography devices, blood tests (e-LIFT + Fibrometer), liver biopsy if necessary (elastometry ≥ 8 kPa and < 15 kPa) | Diagnostic test | Diagnostic Test: e-LIFT |
Primary outcome
Sensitivity of the eLIFT test for advanced liver fibrosis
Time frame: 1 day
Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test
Sensitivity of the Fibrometer test for advanced liver fibrosis
Time frame: 1 day
Rate of patients with advanced liver fibrosis correctly identified by the Fibrometer test
14 secondary outcomes
rate of patients referred to the specialist following the screening procedure, with eLIFT test
Time frame: 1 day
rate of patients referred to the specialist following the screening procedure, with FibroMeter test
Time frame: 1 day
Rate of "unnecessary referrals" to the specialist with eLIFT test
Time frame: 1 month
Rate of "unnecessary referrals" to the specialist with Fibrometer test
Time frame: 1 month
Number of hepatocellular carcinoma adetected following the screening procedure, with comparison between eLIFT and FibroMeter strategies
Time frame: 1 month
Number of gastroesophageal varices at risk of bleeding detected following the screening procedure, with comparison between eLIFT and FibroMeter strategies
Time frame: 1 month
directs costs by type of disease such as ALF, hepatocellular carcinoma, gastroesophageal varices at risk of bleeding with comparison between eLIFT and FibroMeter strategies
Time frame: 1 month
eLIFT and FibroMeter screening procedures as a function of the cause of the underlying liver disease (NAFLD, ALD, or mixed NAFLD+ALD)
Time frame: 1 month
the accuracy of a sequential strategy using eLIFT as first-line test and FibroMeter as second-line test
Time frame: 1 day
patient adherence to the screening of advanced liver fibrosis
Time frame: 1 month
most relevant risk factor of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care
Time frame: 1 day
specialized blood test ELF for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers
Time frame: 1 day
Camden and Islington pathway (FIB4 then ELF) for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers,
Time frame: 1 day
Camden and Islington pathway , with comparison of sequential strategy eLIFT then FibroMeter
Time frame: 1 day
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eLIFT in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Alcoholic Liver Disease (ALD), run by University Hospital, Angers at 13 sites in France.
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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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 William BELLANGER, PH (02 41 73 58 10 ext. +33, william.bellanger@univ-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the eLIFT test for advanced liver fibrosis (time frame: 1 day). 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 30 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.