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

NCT ID: NCT05699018

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1788 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2026-03-13

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.

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.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD); Alcoholic Liver Disease (ALD); Liver Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Diagnostic Test: e-LIFT

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

Group Type: OTHER

eLIFT

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

eLIFT

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

Intervention Type: DIAGNOSTIC_TEST

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:

40% with excessive alcohol consumption 40% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 20% 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ANGERS

Angers, , France

Site Status: RECRUITING

CHU Angers

Angers, , France

Site Status: ACTIVE_NOT_RECRUITING

BECON

Bécon-les-Granits, , France

Site Status: COMPLETED

Chalonnes

Chalonnes-sur-Loire, , France

Site Status: COMPLETED

COMBOURG

Combourg, , France

Site Status: COMPLETED

LIFFRE

Liffré, , France

Site Status: COMPLETED

Montreuil

Montreuil-Bellay, , France

Site Status: COMPLETED

RENNES - Armagnac, Churchill

Rennes, , France

Site Status: NOT_YET_RECRUITING

RENNES - Kennedy

Rennes, , France

Site Status: COMPLETED

CHU Rennes

Rennes, , France

Site Status: ACTIVE_NOT_RECRUITING

SEGRE

Segré, , France

Site Status: COMPLETED

Val Couesnon

Val-Couesnon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

William BELLANGER, PH

Role: CONTACT

william.bellanger@univ-angers.fr

02 41 73 58 10 ext. +33

Marc De Saint Loup

Role: CONTACT

madesaintloup@chu-angers.fr

0241357812 ext. +33

Facility Contacts

David FORTIER, MD

Role: primary

Lise SEIGNEURET, MD

Role: primary

Enora CORNU, MD

Role: primary

enoracornu@yahoo.fr

02 99 98 31 44 ext. +33

Benjamin BASTIAN - princial investigator of Tremblay, MD

Role: backup

Enora CORNU - principal investigator of Antrain, MD

Role: backup

Other Identifiers

2022-A02148-35

Identifier Type: -

Identifier Source: org_study_id