Recruiting
Not applicable
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
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
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)
| Facility | City | Region | Status |
| 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 |
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