Examining liver inflammation in patients with non-alcoholic steatohepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on characterizing the intrahepatic inflammatory microenvironment in patients diagnosed with non-alcoholic steatohepatitis (NASH), a severe form of non-alcoholic fatty liver disease (NAFLD). It aims to identify patients with NASH who are at risk of developing fibrosis and hepatocellular carcinoma (HCC) by utilizing liver fine-needle aspiration for detailed analysis. The study will include patients with significant liver fibrosis and will exclude those with decompensated cirrhosis or secondary causes of liver disease. By understanding the inflammatory processes involved, the study seeks to improve patient management and access to therapeutic trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patient with a clinical diagnosis of NAFLD: steatosis detected on imaging and exclusion of secondary causes of steatosis (drugs, genetics, alcohol consumption \>30 g/d in men and 20 g/d in women, chronic viral infection), in the absence or presence of an associated metabolic syndrome
* and with significant liver fibrosis (≥ F2) on at least one non-invasive test (FibroScan®, Fibrometer®, NAFLD Fibrosis Score);
* Patient of legal age (age ≥ 18 years);
* Patient willing to undergo liver biopsy ;
* Patient consenting to inclusion in the study after being informed and obtaining written consent;
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Decompensated cirrhosis or clinically significant portal hypertension (clinical, radiological or endoscopic signs of portal hypertension; presence of hepatocellular insufficiency);
* Secondary causes of steatosis, including chronic viral hepatitis, drugs, excessive alcohol consumption according to World Health Organization (WHO) criteria (\> 30 g/d in men and 20 g/d in women), genetic mutations;
* Any other cause of liver disease: genetic hemochromatosis, autoimmune liver disease, etc. (non-exhaustive list);
* Presence of HCC at the time of inclusion;
* Contraindications to liver biopsy (identical to those for FNA): coagulation disorders, biliary tract dilatation, intrahepatic tumor;
* Pregnant, parturient or breast-feeding women;
* Persons deprived of their liberty by judicial or administrative decision;
* adults under legal protection (guardianship, curators).

Where it's running

• Service Hepato Gastrologie
  Lyon, Auvergne-Rhône-Alpes, France Recruiting

Study contacts

• Study coordinator: Yasmina CHOUIK, MD
• Email: yasmina.chouik@chu-lyon.fr
• Phone: 04.72.07.12.02

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Everolimus-based calcineurin-free immunosuppression one year after liver transplant

  This trial tests whether switching to or using everolimus with reduced calcineurin inhibitors after year one post-liver transplant can protect kidney function while maintaining graft health in adults at low rejection risk.

  Recruiting Phase 3 Hannover Medical School · Heidelberg, Baden-Wurttemberg and 15 other locations · NCT07739914

• Metastatic liver cancer patient registry from multiple Chinese centers

  This is a registry that collects real-world data on adults with liver metastases to understand patterns and prognosis and to support future research.

  Recruiting at 2 sites Anhui Provincial Hospital · Bengbu, Anhui and 2 other locations · NCT07602504

• Safety and how the drug behaves in adults with moderate to severe liver impairment

  This study tests the safety and how INCB123667 moves through the body when taken by adults with moderate to severe liver impairment.

  Recruiting at 4 sites Phase 1 Incyte Corporation · Chandler, Arizona and 3 other locations · NCT07559474

• Single-probe FibroScan for measuring liver stiffness

  This project will try a single-probe FibroScan to measure liver stiffness in adults with chronic liver disease and compare its results to the standard M and XL probes.

  Recruiting Echosens · Besançon and 3 other locations · NCT07400289

• Using polyene phosphatidylcholine to protect the liver after hepatectomy

  This test checks whether giving polyene phosphatidylcholine before surgery plus magnesium isoglycyrrhizinate after surgery better prevents liver injury in people having laparoscopic liver resection for hepatocellular carcinoma.

  Recruiting Phase 4 Anhui Provincial Hospital · Hefei, Anhui · NCT07150624

• CRISPR-edited donor liver transplant to reduce rejection

  This trial will try transplanting deceased-donor livers that have had key HLA genes removed with CRISPR to see if they cause less rejection in adults needing a liver transplant.

  Recruiting Phase 1/2 American Organ Transplant and Cancer Research Institute LLC · Beijing, Changping · NCT07053488

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.