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"

Obesity Clinical Trial

— LLIFT  

Official title:

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616664
• Other study ID #: 2019_45
• Secondary ID: 2020-A01991-38
• Status: Recruiting
• Start date: February 16, 2021
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Guillaume Lassailly, MD
• Phone: 0320445962
• Email: guillaume.lassailly[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1027
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Metabolic Syndrome
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease
• Obesity

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Région Nord-Pas de Calais, France, RHU PreciNASH Task 1.4

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score	The variables constituting the calculation algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,...) and genetic polymorphism	Baseline
Secondary	The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score	The variables constituting the algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,..), genetic polymorphism.	Baseline
Secondary	Assessment of the correlation between the LLIFT score and the NAS score	The NAS score is a stratification based on steatosis, ballooning and lobular inflammation.	Baseline