Clinical trial NCT04616664: 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"
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"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
NASH - Nonalcoholic Steatohepatitis
Keywords: NAFL
NASH screening
metabolic syndrome
Diagnostic Biomarker
non-invasive biomarker
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: RHU PreciNASH Task 1.4
name: Région Nord-Pas de Calais, France
First posted: 2020-11-05
Enrollment: 1027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are followed in the cardiology, endocrinology, hepatology, hepatologic surgery and bariatric surgery units of the CHU de Lille and regional centers and presente type 2 diabetes or blood pressure hypertension associated with increased hepatic enzyme.

Patients will be referred to the hepatology units and included in the study

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score
timeFrame: Baseline
Secondary outcomes:
measure: The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score
timeFrame: Baseline
measure: Assessment of the correlation between the LLIFT score and the NAS score
timeFrame: Baseline
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Arras
country: France
facility: CH ARRAS
city: Douai
country: France
facility: CH de Douai
city: Lens
country: France
facility: CH LENS
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
city: Lomme
country: France
facility: GHIRCL saint Philibert
city: Valenciennes
country: France
facility: Ch Valenciennes
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Lassailly, MD
role: PRINCIPAL_INVESTIGATOR
References: