Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
SOPRANO
1 other identifier
interventional
1,788
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2026
ExpectedJune 30, 2026
June 1, 2026
3.3 years
December 28, 2022
June 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of the eLIFT test for advanced liver fibrosis
Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test
1 day
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 Outcomes (14)
rate of patients referred to the specialist following the screening procedure, with eLIFT test
1 day
rate of patients referred to the specialist following the screening procedure, with FibroMeter test
1 day
Rate of "unnecessary referrals" to the specialist with eLIFT test
1 month
Rate of "unnecessary referrals" to the specialist with Fibrometer test
1 month
Number of hepatocellular carcinoma adetected following the screening procedure, with comparison between eLIFT and FibroMeter strategies
1 month
- +9 more secondary outcomes
Study Arms (1)
Diagnostic Test: e-LIFT
OTHERonly one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference
Interventions
Diagnostic procedure: elastography devices, blood tests (e-LIFT + Fibrometer), liver biopsy if necessary (elastometry ≥ 8 kPa and \< 15 kPa)
Eligibility Criteria
You may qualify if:
- 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:
- % 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
ANGERS
Angers, 49000, France
CHU Angers
Angers, 49000, France
BAUGE
Baugé-en-Anjou, 49150, France
BECON
Bécon-les-Granits, 49370, France
Chalonnes
Chalonnes-sur-Loire, 49290, France
COMBOURG
Combourg, 35270, France
LIFFRE
Liffré, 35340, France
Montreuil
Montreuil-Bellay, 49260, France
RENNES - Armagnac, Churchill
Rennes, 35000, France
RENNES - Kennedy
Rennes, 35000, France
CHU Rennes
Rennes, 35033, France
SEGRE
Segré, 49500, France
Val Couesnon
Val-couesnon, 35560, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2022
First Posted
January 26, 2023
Study Start
March 13, 2023
Primary Completion
June 12, 2026
Study Completion (Estimated)
September 12, 2026
Last Updated
June 30, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.