Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT05699018

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

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

AI-Powered 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

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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