Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"

NCT ID: NCT04616664

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-16

Study Completion Date

2024-01-17

Brief Summary

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The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease.

The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.

Detailed Description

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Conditions

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Obesity NASH - Nonalcoholic Steatohepatitis

Keywords

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NAFL NASH screening metabolic syndrome Diagnostic Biomarker non-invasive biomarker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with 1 at least of the following metabolic criteria :

* BMI \> 30 kg/m²,
* Type 2 diabetes (glycemia \> 1.26 g/L or under therapy)
* hypertension (\> 140 mmHg / 90 mmHg or under therapy) associated with increased hepatic enzymes
* Indication of NAFLD evaluation
* Patients written consent
* Affiliated to a social insurance

Exclusion Criteria

* Contraindications for liver biopsy or MRI.
* Other confounding cause of liver disease (HCV, HBV, HCC, autoimmune liver disease, Hemochromatosis, Wilson disease.
* alcohol consumption higher than 140g/week for women and 210g/week for men
* Previous history of alcohol abuse (addiction).
* Eluding stent \< 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks.
* Hepatocellular carcinoma
* Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)
* Pregnant or breastfeeding women.
* Drug abuse within the past year.
* Mentally unbalanced patients, under supervision or guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RHU PreciNASH Task 1.4

UNKNOWN

Sponsor Role collaborator

Région Nord-Pas de Calais, France

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Lassailly, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Chu Amiens Picardie

Amiens, , France

Site Status

CH ARRAS

Arras, , France

Site Status

CH de Douai

Douai, , France

Site Status

CH LENS

Lens, , France

Site Status

Hop Claude Huriez Chu Lille

Lille, , France

Site Status

GHIRCL saint Philibert

Lomme, , France

Site Status

Ch Valenciennes

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01991-38

Identifier Type: OTHER

Identifier Source: secondary_id

2019_45

Identifier Type: -

Identifier Source: org_study_id