Status:
RECRUITING
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD And/or Alcoholic Patients
Lead Sponsor:
University Hospital, Angers
Conditions:
Non-alcoholic Fatty Liver Disease (NAFLD)
Alcoholic Liver Disease (ALD)
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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 pri...
Detailed Description
Chronic liver diseases (CLD) are responsible for 17 000 deaths each year in France (cirrhosis: 8 000, liver cancer: 9 000). Non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD) ...
Eligibility 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
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 13 2026
Estimated Enrollment :
1788 Patients enrolled
Trial Details
Trial ID
NCT05699018
Start Date
March 13 2023
End Date
March 13 2026
Last Update
January 23 2025
Active Locations (12)
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1
ANGERS
Angers, France, 49000
2
CHU Angers
Angers, France, 49000
3
BECON
Bécon-les-Granits, France, 49370
4
Chalonnes
Chalonnes-sur-Loire, France, 49290