Liver Fibrosis Clinical Trial
— SOPRANOOfficial title:
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
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.
Status | Recruiting |
Enrollment | 1788 |
Est. completion date | December 15, 2025 |
Est. primary completion date | May 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
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) - 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 |
Country | Name | City | State |
---|---|---|---|
France | ANGERS | Angers | |
France | CHU Angers | Angers | |
France | BECON | Bécon-les-Granits | |
France | Chalonnes | Chalonnes-sur-Loire | |
France | COMBOURG | Combourg | |
France | LIFFRE | Liffré | |
France | Montreuil | Montreuil-Bellay | |
France | CHU Rennes | Rennes | |
France | RENNES - Armagnac, Churchill | Rennes | |
France | RENNES - Kennedy | Rennes | |
France | SEGRE | Segré | |
France | Val Couesnon | Val-Couesnon |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of the eLIFT test for advanced liver fibrosis | Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test | 1 day | |
Primary | Sensitivity of the Fibrometer test for advanced liver fibrosis | Rate of patients with advanced liver fibrosis correctly identified by the Fibrometer test | 1 day | |
Secondary | rate of patients referred to the specialist following the screening procedure, with eLIFT test | Rate of patients with positive screening test (eLIFT =8) | 1 day | |
Secondary | rate of patients referred to the specialist following the screening procedure, with FibroMeter test | Rate of patients with positive screening test (FibroMeter =0.46) | 1 day | |
Secondary | Rate of "unnecessary referrals" to the specialist with eLIFT test | Rate of patients with positive screening test (eLIFT =8) but without final diagnosis of ALF | 1 month | |
Secondary | Rate of "unnecessary referrals" to the specialist with Fibrometer test | Rate of patients with positive screening test (FibroMeter =0.46) but without final diagnosis of ALF | 1 month | |
Secondary | Number of hepatocellular carcinoma adetected following the screening procedure, with comparison between eLIFT and FibroMeter strategies | Number of patients with hepatocellular carcinoma (diagnosed on MRI by the recommended radiological criteria: hyperenhancement on the arterial phase and washout on the portal venous phase, or by liver biopsy); | 1 month | |
Secondary | Number of gastroesophageal varices at risk of bleeding detected following the screening procedure, with comparison between eLIFT and FibroMeter strategies | Number of patients with gastroesophageal varices at risk of bleeding (diagnosed by upper-gastrointestinal endoscopy: medium-large varices or small varices with red wall marks) | 1 month | |
Secondary | directs costs by type of disease such as ALF, hepatocellular carcinoma, gastroesophageal varices at risk of bleeding with comparison between eLIFT and FibroMeter strategies | Mean direct cost per patient; mean direct cost generated to detect one patient with ALF, one patient with hepatocellular carcinoma, one patient with gastroesophageal varices at risk of bleeding | 1 month | |
Secondary | eLIFT and FibroMeter screening procedures as a function of the cause of the underlying liver disease (NAFLD, ALD, or mixed NAFLD+ALD) | Rate of patient with ALF, positive screening test, hepatocellular carcinoma, gastroesophageal varices at risk of bleeding, and mean cost, with comparison between NAFLD, ALD, and mixed NAFLD+ALD subgroups | 1 month | |
Secondary | the accuracy of a sequential strategy using eLIFT as first-line test and FibroMeter as second-line test | Rate of patients with ALF diagnosed by a stepwise algorithm using eLIFT =8 then, if positive, FibroMeter =0.46 | 1 day | |
Secondary | patient adherence to the screening of advanced liver fibrosis | Rate of patients included in the study who did not achieve the required screening procedures | 1 month | |
Secondary | most relevant risk factor of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care | Risk factors among clinical characteristics, alcohol consumption, metabolic parameters independently associated with ALF diagnosis | 1 day | |
Secondary | specialized blood test ELF for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers | Same endpoints than primary and secondaries 1 to 11, but using the recommended 9.8 threshold for ELF | 1 day | |
Secondary | Camden and Islington pathway (FIB4 then ELF) for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers, | Same endpoints than primary and secondaries 1 to 11, but using using the Camden and Islington pathway | 1 day | |
Secondary | Camden and Islington pathway , with comparison of sequential strategy eLIFT then FibroMeter | Same endpoints than primary and secondaries 1 to 11, but using using the Camden and Islington pathway | 1 day |
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