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"

Recruiting

• Conditions: Obesity; NASH - Nonalcoholic Steatohepatitis

• Registration Number: NCT04616664
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-05
• Study Start: 2021-02-16
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1027

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score	Baseline	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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

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