NCT04616664Completed
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"
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 158 (actual)
- First submitted
- 6 Oct 2020
- Start date
- 16 Feb 2021
- Primary completion date
- 17 Jan 2024
- Lead sponsor
- University Hospital, Lille
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04616664
What you commit to
- Study type: Observational
- Participants enrolled: 158
- From 16 Feb 2021 to the primary completion date, 17 Jan 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of alcohol abuse (addiction).
- Drug abuse within the past year.
Other illness
- Other confounding cause of liver disease (HCV, HBV, HCC, autoimmune liver disease, Hemochromatosis, Wilson disease.
- Eluding stent \< 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks.
- Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)
Other
- Contraindications for liver biopsy or MRI.
- alcohol consumption higher than 140g/week for women and 210g/week for men
- Hepatocellular carcinoma
- Pregnant or breastfeeding women.
- Mentally unbalanced patients, under supervision or guardianship
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CH Arras Coordinator of this site? Confirm its status | Arras | France | Unknown status |
| CH de Douai Coordinator of this site? Confirm its status | Douai | France | Unknown status |
| CH Lens Coordinator of this site? Confirm its status | Lens | France | Unknown status |
| Hop Claude Huriez Chu Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| GHIRCL saint Philibert Coordinator of this site? Confirm its status | Lomme | France | Unknown status |
| CH Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.