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NCT05699018 | Recruiting | Non-alcoholic Fatty Liver Disease (NAFLD)


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

University Hospital, Angers

Brief 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.

Condition or disease

Non-alcoholic Fatty Liver Disease (NAFLD)

Alcoholic Liver Disease (ALD)

Liver Fibrosis

Intervention/treatment

eLIFT

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 1788 participants
Masking : None (Open Label)
Primary Purpose : Screening
Official Title : Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
Actual Study Start Date : March 13, 2023
Estimated Primary Completion Date : May 15, 2025
Estimated Study Completion Date : December 15, 2025
Arm Intervention/treatment

Other: Diagnostic Test: e-LIFT

only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference

Diagnostic Test: eLIFT

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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)
    • 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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

France,

ANGERS

Angers, France, 49000

Active, not recruiting

France,

Chu Ungers

Angers, France, 49000

Not yet recruiting

France,

BECON

Bécon-les-Granits, France, 49370

Not yet recruiting

France,

Chalonnes

Chalonnes-sur-Loire, France, 49290

Not yet recruiting

France,

COMBOURG

Combourg, France, 35270

Recruiting

France,

LIFFRE

Delivered, France, 35340

Completed

France,

Montreuil

Montreuil-Bellay, France, 49260

Not yet recruiting

France,

RENNES - Armagnac, Churchill

Rennes, France, 35000

Not yet recruiting

France,

RENNES - Kennedy

Rennes, France, 35000

Active, not recruiting

France,

Chu rns

Rennes, France, 35033

Completed

France,

SECRET

Segre, France, 49500

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