Actively Recruiting
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD And/or Alcoholic Patients
Led by University Hospital, Angers · Updated on 2025-01-23
1788
Participants Needed
12
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD And/or Alcoholic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years
- Diagnosis of NAFLD and/or ALD defined by at least one of the following: excessive alcohol consumption (>210 g/week for men, >140 g/week for women), type 2 diabetes, or at least two metabolic factors (BMI 25 kg/m2, elevated blood pressure, dyslipidemia, hyperferritinemia)
- Bright liver on ultrasonography without steatosis-inducing drugs
- For last three primary care centers: patients with excessive alcohol consumption and/or type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments with stratified inclusion (40% excessive alcohol consumption, 40% type 2 diabetes, 20% both conditions)
- Agreement to blood sample collection at a local laboratory
- Covered by or entitled to medical care insurance
- Signed informed consent
You will not qualify if you...
- Currently receiving specialized follow-up for chronic liver disease
- Poor short-term health prognosis incompatible with screening
- Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- Acute infection
- Pregnancy or breastfeeding
- Persons in detention by judicial or administrative decision
- Admission to health or social establishment for non-research purposes
- Subject to legal protection measures
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
ANGERS
Angers, France, 49000
Actively Recruiting
2
CHU Angers
Angers, France, 49000
Active, Not Recruiting
3
BECON
Bécon-les-Granits, France, 49370
Completed
4
Chalonnes
Chalonnes-sur-Loire, France, 49290
Completed
5
COMBOURG
Combourg, France, 35270
Completed
6
LIFFRE
Liffré, France, 35340
Completed
7
Montreuil
Montreuil-Bellay, France, 49260
Completed
8
RENNES - Armagnac, Churchill
Rennes, France, 35000
Not Yet Recruiting
9
RENNES - Kennedy
Rennes, France, 35000
Completed
10
CHU Rennes
Rennes, France, 35033
Active, Not Recruiting
11
SEGRE
Segré, France, 49500
Completed
12
Val Couesnon
Val-Couesnon, France, 35560
Actively Recruiting
Research Team
W
William BELLANGER, PH
CONTACT
M
Marc De Saint Loup
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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