NCT05699018 Screening in Primary Care of Advanced Liver Fibrosis in NAFLD And/or Alcoholic Patients
| NCT ID | NCT05699018 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Non-alcoholic Fatty Liver Disease (NAFLD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,788 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2025-12-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,788 participants in total. It began in 2023-03-13 with a primary completion date of 2025-12-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 primary care centers.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05699018 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Non-alcoholic Fatty Liver Disease (NAFLD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05699018 currently recruiting?
Yes, NCT05699018 is actively recruiting participants. Contact the research team at william.bellanger@univ-angers.fr for enrollment information.
Where is the NCT05699018 trial being conducted?
This trial is being conducted at Angers, France, Angers, France, Bécon-les-Granits, France, Chalonnes-sur-Loire, France and 8 additional locations.
Who is sponsoring the NCT05699018 clinical trial?
NCT05699018 is sponsored by University Hospital, Angers. The trial plans to enroll 1,788 participants.