Screening for advanced liver fibrosis in patients with fatty liver disease or alcohol-related liver issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare two blood tests, eLIFT and FibroMeter, for detecting advanced liver fibrosis in patients suffering from Non-alcoholic Fatty Liver Disease (NAFLD) and/or Alcoholic Liver Disease (ALD) in primary care settings. Chronic liver diseases are a significant health concern in France, leading to thousands of deaths annually, and many patients remain undiagnosed until complications arise. By utilizing non-invasive blood tests, the study seeks to improve early identification of patients who need specialist referral, thereby enhancing management and outcomes. General practitioners will be equipped with a simpler and more accessible method for screening liver fibrosis.

Why it matters

Who can join: the full rules

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

Where it's running

• Bauge
  Baugé-en-Anjou, France Recruiting
• Angers
  Angers, France Completed
• CHU Angers
  Angers, France Active not recruiting
• Becon
  Bécon-les-Granits, France Completed
• Chalonnes
  Chalonnes-sur-Loire, France Completed
• Combourg
  Combourg, France Completed

Study contacts

• Study coordinator: William BELLANGER, PH
• Email: william.bellanger@univ-angers.fr
• Phone: 02 41 73 58 10

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD

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• Endohepatology-based reclassification of treatment indication in high-risk MASLD

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• Umbilical cord stem cells added during Kasai to help biliary atresia

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• ECC4703 with Sulfasalazine and Pitavastatin in adults with NAFLD and dyslipidemia

  This early study tests whether adding ECC4703 to sulfasalazine and pitavastatin is safe and how the body handles the combination in adults with fatty liver disease and high cholesterol.

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• Taiwan green propolis for MASLD and lipid/metabolic issues

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.