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
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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COMPLETED
158 participants
OBSERVATIONAL
2021-02-16
2024-01-17
Brief Summary
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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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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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RHU PreciNASH Task 1.4
UNKNOWN
Région Nord-Pas de Calais, France
OTHER
University Hospital, Lille
OTHER
Responsible Party
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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
CH ARRAS
Arras, , France
CH de Douai
Douai, , France
CH LENS
Lens, , France
Hop Claude Huriez Chu Lille
Lille, , France
GHIRCL saint Philibert
Lomme, , France
Ch Valenciennes
Valenciennes, , France
Countries
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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