An interventional study of Liver Fine-Needle Aspiration in Liver Diseases, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
Non-alcoholic fatty liver disease (NAFLD) is a nosological entity that groups together non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). Unlike NAFL, NASH is characterized by intrahepatic inflammation, and is solely at risk of progression to cirrhosis and hepatocellular carcinoma (HCC).
It is currently estimated that NAFLD affects approximately 25% of the world's adult population, and its incidence is rising in all regions of the world. Nevertheless, of all patients with NAFLD, only \~25% have NASH.
Identifying patients with NASH is therefore crucial, determining the need for follow-up to detect the onset of fibrosis and/or HCC, and eventual access to therapeutic trials. Furthermore, intrahepatic inflammation, the initial driver of NASH, appears to play an important role in the development of fibrosis and HCC, which can occur in the absence of cirrhosis in these patients. However, few studies have been carried out in humans to date, with data mainly coming from mouse models.
An innovative technique, Fine-Needle Aspiration (FNA), enables to obtain cells from the liver compartment, including large numbers of immune cells. In participants with NAFLD and indication of liver biopsy, a FNA will also be performed. Forty patients will be included, with \~75% of NASH and \~25% of NAFL expected. The investigators will study the phenotypic and functional characteristics of human intrahepatic inflammatory cells obtained by the FNA with different innovative techniques (RNAseq, multiparameter immunophenotyping, single-cell secretome and phosphoproteome). Peripheral Blood Mononuclear Cells and circulating microRNAs, known to regulate immune responses, will also be analysed.
The hypothesis of Profile-NASH is that intrahepatic inflammatory profiles differ between NASH and NAFL, and is associated with fibrosis progression and carcinogenesis.
This pilot study, based on high-definition technologies, will provide precise new insights into the quality of intrahepatic inflammation and the mechanisms favoring the transition from NAFL to NASH and its progression. Precise analysis of the intrahepatic inflammatory microenvironment will enable the investigators to identify new players in the pathogenesis of NASH, and potential future therapeutic targets.
824 studies on the registry are indexed under Liver Diseases; 152 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 521 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At the time of inclusion, when liver biopsy will be performed as part of routine medical management, fine-needle aspiration and blood sampling will also be made in all patients. The procedure will be performed in the Day Hospital, immediately after the liver biopsy and after the same local anaesthetic. Specific blood sampling will be made the same day (20mL of plasma in Ethylenediaminetetraacetic Acid Tetrasodium (EDTA) tubes and 20 mL of plasma in heparin tubes). Clinical information will be collected in electronic Case Report Form (e-CRF). After the procedure, the patient will be monitored as part of the usual protocol. No follow-up data are expected with Profile-NASH.
Other: Liver Fine-Needle Aspiration
At the time of inclusion, when liver biopsy will be performed as part of routine medical management, fine-needle aspiration will also be made in all patients. The procedure will be performed in the Day Hospital, immediately after the liver biopsy.
The primary endpoint is the comparison of transcriptomic profiles between NAFL and NASH patients.
Cells collected from the RNA extraction plasma cell will be analyzed with technique: \- Transcriptomic analysis (RNA-Seq) The data obtained by these analyses will be compared between patients with NASH vs. NAFL, using multiple testing corrections.
Time frame: At the time of the procedure liver biopsy at Day 1
The primary endpoint is the secretome and single-cell phosphoproteome between NAFL and NASH patients.
Cells collected from the FNA procedure will be analyzed with technique: \- Single-cell secretome and phosphoproteome by ISOPLEXIS® The data obtained by these analyses will be compared between patients with NASH vs. NAFL, using multiple testing corrections.
Time frame: At the time of the procedure liver biopsy at Day 1
The primary endpoint is the immunophenotyping of intrahepatic mononuclear cells between NAFL and NASH patients.
Cells collected from the peripheral blood mononuclear cells will be analyzed with technique: \- Multiparameter immunophenotyping by spectral cytometry The data obtained by these analyses will be compared between patients with NASH vs. NAFL, using multiple testing corrections.
Time frame: At the time of the procedure liver biopsy at Day 1
Comparison of transcriptome profiles between patients with significant liver fibrosis (≥ F2) and patients without significant fibrosis (F0/F1).
This secondary outcome is a subgroup analysis of the primary outcome, only in the group " NASH ", between patients with or without significant liver fibrosis. The classification of patients according to their fibrosis stage will be made after histological evaluation of the liver biopsy. Cells collected from the RNA extraction plasma cell will be analyzed with technique: \- Transcriptomic analysis (RNA-Seq)
Time frame: At the time of the procedure liver biopsy at Day 1
Comparison of secretome and single-cell phosphoproteome between patients with significant liver fibrosis (≥ F2) and patients without significant fibrosis (F0/F1).
This secondary outcome is a subgroup analysis of the primary outcome, only in the group " NASH ", between patients with or without significant liver fibrosis. The classification of patients according to their fibrosis stage will be made after histological evaluation of the liver biopsy. Cells collected from the FNA procedure will be analyzed with technique: \- Single-cell secretome and phosphoproteome by ISOPLEXIS®
Time frame: At the time of the procedure liver biopsy at Day 1
Comparison of the immunophenotyping profiles of intrahepatic mononuclear cells between patients with significant liver fibrosis (≥ F2) and patients without significant fibrosis (F0/F1).
This secondary outcome is a subgroup analysis of the primary outcome, only in the group " NASH ", between patients with or without significant liver fibrosis. The classification of patients according to their fibrosis stage will be made after histological evaluation of the liver biopsy. Cells collected from the peripheral blood mononuclear cells will be analyzed with technique: \- Multiparameter immunophenotyping by spectral cytometry
Time frame: At the time of the procedure liver biopsy at Day 1
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