Screening for advanced liver fibrosis in patients with fatty liver disease or alcohol-related liver issues
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD And/or Alcoholic Patients
This study is testing two blood tests to see which one better helps doctors find advanced liver damage in people with fatty liver disease or alcohol-related liver problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1788 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | methotrexate |
| Locations | 12 sites (Angers and 11 other locations) |
| Trial ID | NCT05699018 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with NAFLD and/or ALD, particularly those with risk factors such as excessive alcohol consumption or metabolic syndrome.
Not a fit: Patients without NAFLD or ALD, or those who do not meet the inclusion criteria, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of liver fibrosis, potentially reducing the incidence of cirrhosis and improving patient survival rates.
How similar studies have performed: Other studies have shown promise in using non-invasive blood tests for liver fibrosis screening, indicating that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 11 other locations
- Angers — Angers, France (Recruiting)
- CHU Angers — Angers, France (Active_not_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 (Not_yet_recruiting)
- RENNES - Kennedy — Rennes, France (Completed)
- CHU Rennes — Rennes, France (Active_not_recruiting)
- Segre — Segré, France (Completed)
- Val Couesnon — Val-Couesnon, France (Recruiting)
Study contacts
- Study coordinator: William BELLANGER, PH
- Email: william.bellanger@univ-angers.fr
- Phone: 02 41 73 58 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.