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Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients

Study acronym: SOPRANO
StatusRecruiting
PhaseNot applicable
Started2023-03-13
View on ClinicalTrials.gov ↗

Amendment history

2026-06-26
Study Status v9
Completion moved earlier: 2026-10-13 → 2026-09-12
Primary completion dateestimated 2026-06-13→confirmed 2026-06-12
2026-06-12
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations, IPDSharing v8
Primary completion date2025-12-13→2026-06-13
Completion date2026-03-13→2026-10-13
Study sites12→13
Eligibility criteria-1 characters
[...] diabetic treatments, AND with the following stratification: 4030% with excessive alcohol consumption 4065% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 205% with both conditions (excessive alcohol consumption, AND t [...]
Study titlerevised
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD Andand/or Alcoholic Patients
2025-01-20
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 12 sites
2025-01-09
Study Status, Eligibility, Contacts/Locations v6
Eligibility criteria-130 characters
[...] OR type 2 diabetes treated with insulin and/or at least two oralother anti-diabetic treatments, AND with the following stratification: 40% with excessive alcohol consumption "alone" (without diabetes condition as defined above) / 40% with type 2 diabetes treated with insulin and/or at least two oralother anti-diabetic treatments "alone" (without excessive alcohol consumption condition as defined above) / 20% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two oralother anti-diabetic treatments) Patient's agreement to have a blo [...]
Study sitescontacts updated at 1 of 12 sites
2024-12-10
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v5
Primary completion date2025-05-15→2025-12-13
Completion date2025-12-15→2026-03-13
Eligibility criteria+780 characters
[...] temic 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 oral an [...] Patient's agreement to have a blood sample collected in a lo [...]
Study sitesdetails revised at 3 of 12 sites
Study titlerevised
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD andAnd/or Alcoholic Patients
Show 4 earlier versions
2024-05-14
Study Status, Arms and Interventions, Contacts/Locations v4
Study sites11→12
2023-12-06
Study Status, Contacts/Locations v3
Primary completion date2024-09-15→2025-05-15
Completion date2024-09-15→2025-12-15
Study sites6→11
2023-05-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-02-20→confirmed 2023-03-13
Study sitesdetails revised at 6 of 6 sites
2023-01-26
Study Status v1
Start date2023-01-15→2023-02-20
2023-01-16
Original filing
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 Details
NCT Number NCT05699018
Lead Sponsor University Hospital, Angers
Conditions Non-alcoholic Fatty Liver Disease (NAFLD), Alcoholic Liver Disease (ALD), Liver Fibrosis
Enrollment 1,788 participants
Start Date 2023-03-13
Primary Completion 2026-06-12 (estimated)
Study Completion 2026-09-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-30