Simple blood tests could catch liver damage early in Doctor's offices
NCT ID NCT05699018
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study aims to see which of two blood tests, eLIFT or FibroMeter, is better at finding advanced liver scarring (fibrosis) in people with fatty liver disease or alcohol-related liver disease. About 1,788 adults from primary care clinics will take both tests. The goal is to improve early detection so patients can get specialist care sooner.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,788 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * NAFLD and/or ALD patient defined by at least 1 of the following criteria: * Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women) * Type 2 diabetes * at least 2 metabolic factors among BMI higher than or equal to 25 kg / m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory) * Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate) Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria: * Excessive alcohol consumption: \>210 g/week in men or \>140 g/week in women, * AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments, * AND with the following stratification: 30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments) * Patient's agreement to have a blood sample collected in a local laboratory participating in the study * Subjects covered by or having the rights to medical care assurance * Written informed consent obtained from subject Exclusion Criteria: * Already ongoing specialized follow-up for a chronic liver disease * Altered health status with poor short-term prognosis, not compatible with a screening procedure * Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome) * Acute infection * Pregnancy, breastfeeding * Persons in detention by judicial or administrative decision * Person admitted to a health or social establishment for purposes other than research * Person subject to a legal protection measure * Person unable to express consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ANGERS
COMPLETEDAngers, 49000, France
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BAUGE
RECRUITINGBaugé-en-Anjou, 49150, France
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BECON
COMPLETEDBécon-les-Granits, 49370, France
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CHU Angers
ACTIVE_NOT_RECRUITINGAngers, 49000, France
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CHU Rennes
ACTIVE_NOT_RECRUITINGRennes, 35033, France
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COMBOURG
COMPLETEDCombourg, 35270, France
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Chalonnes
COMPLETEDChalonnes-sur-Loire, 49290, France
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LIFFRE
COMPLETEDLiffré, 35340, France
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Montreuil
COMPLETEDMontreuil-Bellay, 49260, France
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RENNES - Armagnac, Churchill
COMPLETEDRennes, 35000, France
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RENNES - Kennedy
COMPLETEDRennes, 35000, France
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SEGRE
COMPLETEDSegré, 49500, France
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Val Couesnon
COMPLETEDVal-couesnon, 35560, France
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Other studies related to the condition(s) this trial covers.
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