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
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two blood tests, eLIFT and FibroMeter, to screen for advanced liver fibrosis in patients with Non-alcoholic Fatty Liver Disease (NAFLD) and Alcoholic Liver Disease (ALD) in primary care settings. These liver conditions affect a large portion of the adult population and can lead to serious complications if fibrosis progresses. The study aims to evaluate how well these tests help general practitioners identify patients who need specialist referral, as current physical exams and usual tests often miss advanced fibrosis. The study involves a diagnostic evaluation using blood tests (eLIFT and FibroMeter) alongside elastography devices and liver biopsy when needed. Only one arm is included since this is a diagnostic study. The tests are assessed for sensitivity and specificity in detecting advanced liver fibrosis. The study is conducted in primary care centers with patients aged 40 to 80 years who have NAFLD and/or ALD and meet specific risk criteria. Participants will undergo blood testing and elastography, and liver biopsy may be performed if indicated by elastometry results. Researchers will measure the sensitivity of each test for detecting advanced fibrosis and track patient referrals to specialists. Additional outcomes include rates of unnecessary referrals, detection of liver cancer or varices, patient adherence to screening, and cost analysis. The study includes follow-up assessments within one month after screening to gather comprehensive data on screening effectiveness and patient outcomes.
CONDITIONS
Brief 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 including BMI ≥ 25 kg/m2, elevated blood pressure, dyslipidemia, or hyperferritinemia
- Bright liver on ultrasound without use of steatosis-inducing drugs
- For later enrolling centers: excessive alcohol consumption and/or type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments with specified stratification
- Agreement to provide a blood sample at a participating laboratory
- Covered by medical care insurance or rights
- Written informed consent obtained
You will not qualify if you...
- Already receiving specialized follow-up for chronic liver disease
- Poor health status with short-term poor prognosis incompatible with screening
- Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- Acute infection
- Pregnancy or breastfeeding
- Persons detained by judicial or administrative decision
- Persons admitted to health or social establishments for reasons other than research
- Persons under legal protection measures
- Persons unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants undergo blood tests and elastography to screen for advanced liver fibrosis in a primary care setting.
1 visit (in-person) for blood tests and elastography
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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