An interventional study of eLIFT in Non-alcoholic Fatty Liver Disease (NAFLD), Alcoholic Liver Disease (ALD) and Liver Fibrosis, sponsored by University Hospital, Angers. Recruiting at 13 sites in France. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Screening
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.
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 1,788 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference
Diagnostic Test: eLIFT
Diagnostic procedure: elastography devices, blood tests (e-LIFT + Fibrometer), liver biopsy if necessary (elastometry ≥ 8 kPa and \< 15 kPa)
Sensitivity of the eLIFT test for advanced liver fibrosis
Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test
Time frame: 1 day
Sensitivity of the Fibrometer test for advanced liver fibrosis
Rate of patients with advanced liver fibrosis correctly identified by the Fibrometer test
Time frame: 1 day
rate of patients referred to the specialist following the screening procedure, with eLIFT test
Rate of patients with positive screening test (eLIFT ≥8)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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);
Time frame: 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)
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
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
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)
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
Time frame: 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
Time frame: 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
Time frame: 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
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
Same endpoints than primary and secondaries 1 to 11, but using the recommended 9.8 threshold for ELF
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,
Same endpoints than primary and secondaries 1 to 11, but using using the Camden and Islington pathway
Time frame: 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
Time frame: 1 day
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Plan to share: 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.
Supporting information: Study protocol
Time frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
Access criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Jun 2026, 38 months.
Of 357 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 38 months is above that.
Counting every sponsor, half of 385 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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