RecruitingNot ApplicableNCT05699018

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


Sponsor

University Hospital, Angers

Enrollment

1,788 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria13

  • 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:
  • % 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 Criteria9

  • 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

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Interventions

DIAGNOSTIC_TESTeLIFT

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


Locations(12)

ANGERS

Angers, France

CHU Angers

Angers, France

BECON

Bécon-les-Granits, France

Chalonnes

Chalonnes-sur-Loire, France

COMBOURG

Combourg, France

LIFFRE

Liffré, France

Montreuil

Montreuil-Bellay, France

RENNES - Armagnac, Churchill

Rennes, France

RENNES - Kennedy

Rennes, France

CHU Rennes

Rennes, France

SEGRE

Segré, France

Val Couesnon

Val-Couesnon, France

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NCT05699018


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