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Recruiting Not applicable

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

NCT05699018 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-03-13
Last updated
2026-06-30

Condition(s) studied

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

Investigational drug(s) / intervention(s)

eLIFT

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

Study 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

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Sensitivity of the eLIFT test for advanced liver fibrosis — 1 day
    Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test
  • Sensitivity of the Fibrometer test for advanced liver fibrosis — 1 day
    Rate of patients with advanced liver fibrosis correctly identified by the Fibrometer test

Trial sites (13)

FacilityCityRegionStatus
ANGERS Angers France Completed
CHU Angers Angers France Active Not Recruiting
BAUGE Baugé-en-Anjou France Recruiting
BECON Bécon-les-Granits France Completed
Chalonnes Chalonnes-sur-Loire France Completed
COMBOURG Combourg France Completed
LIFFRE Liffré France Completed
Montreuil Montreuil-Bellay France Completed
RENNES - Armagnac, Churchill Rennes France Completed
RENNES - Kennedy Rennes France Completed
CHU Rennes Rennes France Active Not Recruiting
SEGRE Segré France Completed
Val Couesnon Val-couesnon France Completed
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05699018 on ClinicalTrials.gov ↗ ← All trials in France