Status:

RECRUITING

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

Lead Sponsor:

University Hospital, Angers

Conditions:

Non-alcoholic Fatty Liver Disease (NAFLD)

Alcoholic Liver Disease (ALD)

Eligibility:

All Genders

40-80 years

Phase:

NA

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 pri...

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) ...

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

Key Trial Info

Start Date :

March 13 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 13 2026

Estimated Enrollment :

1788 Patients enrolled

Trial Details

Trial ID

NCT05699018

Start Date

March 13 2023

End Date

March 13 2026

Last Update

January 23 2025

Active Locations (12)

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Page 1 of 3 (12 locations)

1

ANGERS

Angers, France, 49000

2

CHU Angers

Angers, France, 49000

3

BECON

Bécon-les-Granits, France, 49370

4

Chalonnes

Chalonnes-sur-Loire, France, 49290