Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
ID05699018

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

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Frequently Asked Questions

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