Actively Recruiting
Screening for Advanced Liver Fibrosis in NAFLD and Alcoholic Liver Disease Patients Comparing eLIFT and FibroMeter Blood Tests in Primary Care
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
Researchers are evaluating two blood tests, eLIFT and FibroMeter, to screen for advanced liver fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) and/or alcoholic liver disease (ALD) in primary care settings. These chronic liver diseases are common and can lead to serious complications if advanced fibrosis is not detected early. General practitioners often find it challenging to identify patients with advanced fibrosis because routine exams and tests may appear normal. The study compares the eLIFT test, designed for easy use by general practitioners with simple calculation, to the more specialized FibroMeter test. Both tests are blood-based and aim to detect advanced liver fibrosis. Patients may also undergo elastography, a device-based liver stiffness measurement, or liver biopsy if needed. The study is conducted in primary care centers where patients with NAFLD and/or ALD will be screened using these tests. Participants provide blood samples and undergo clinical evaluations during the study. Researchers will measure how sensitive each test is in detecting advanced liver fibrosis. The study includes collecting blood samples at local laboratories and monitoring outcomes such as test sensitivity on the same day. The total participation timeframe includes initial screening and diagnostic testing procedures within one day.
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
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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
M
Marc De Saint Loup
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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