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"

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04616664

Collaborator

RHU PreciNASH Task 1.4 (Other), Région Nord-Pas de Calais, France (Other)

1,027

Enrollment

Locations

39.5

Anticipated Duration (Months)

171.2

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity NASH - Nonalcoholic Steatohepatitis

Study Design

Study Type:

Observational

Anticipated Enrollment :

1027 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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"

Actual Study Start Date :

Feb 16, 2021

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Chu Amiens Picardie	Amiens	France
2	CH ARRAS	Arras	France
3	CH LENS	Lens	France
4	Hop Claude Huriez Chu Lille	Lille	France	59037
5	GHIRCL saint Philibert	Lomme	France
6	Ch Valenciennes	Valenciennes	France