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Recruiting NCT05699018

Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients

No phase Interventional Non-alcoholic Fatty Liver Disease (NAFLD) Alcoholic Liver Disease (ALD) Liver Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eLIFT.
Who it may be relevant to
Registry conditions: Non-alcoholic Fatty Liver Disease (NAFLD), Alcoholic Liver Disease (ALD), Liver Fibrosis. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test eLIFT
    Diagnostic procedure: elastography devices, blood tests (e-LIFT + Fibrometer), liver biopsy if necessary (elastometry ≥ 8 kPa and \< 15 kPa)

Primary outcome measures

  • Sensitivity of the eLIFT test for advanced liver fibrosis [Time frame: 1 day]
  • Sensitivity of the Fibrometer test for advanced liver fibrosis [Time frame: 1 day]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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:

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

France · 13 centers
  • ANGERS — Angers
  • CHU Angers — Angers
  • BAUGE — Baugé-en-Anjou
  • BECON — Bécon-les-Granits
  • Chalonnes — Chalonnes-sur-Loire
  • COMBOURG — Combourg
  • LIFFRE — Liffré
  • Montreuil — Montreuil-Bellay
  • … and 5 more centers

Identifiers

NCT: NCT05699018 · 2022-A02148-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗