Liver DiseasesProfil-NASHNCT06152250
Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis
A study testing Liver Fine-Needle Aspiration in people with Liver Diseases, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Liver Fine-Needle Aspiration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2023to 29 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service Hepato Gastrologie
Lyon, Auvergne-Rhône-Alpes, 69004
Yasmina CHOUIK, MD, 0472071202 ext. +33, yasmina.chouik@chu-lyon.fr
About this study
Official title: Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis by Transcriptomics, Immunophenotyping and Functional Proteomics: Profil-NASH
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.
Read more
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.
- Conditions
- Liver Diseases
- Being tested
- Liver Fine-Needle Aspiration
- Keywords
- intra-hepatic immune responses, liver inflammation, non-alcoholic fatty liver, Non-alcoholic fatty liver disease
- Medical subject headings
- Liver Diseases, Hepatitis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver Fine-Needle AspirationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Liver Fine-Needle Aspiration, blood sampling and clinical evaluation | Other | 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. Receives: Other: Liver Fine-Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the time of the procedure liver biopsy at Day 1
Secondary outcomes (3)
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)
Measured: 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®
Measured: 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
Measured: At the time of the procedure liver biopsy at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start29 Jan 2023
- Primary completion29 Jan 2029 (estimated)
- Study completion29 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Liver Fine-Needle Aspiration, blood sampling and clinical evaluation
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152250
- Sponsor's protocol ID
- 69HCL22_1059
- Acronym
- Profil-NASH
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis by Transcriptomics, Immunophenotyping and Functional Proteomics: Profil-NASH
- ClinicalTrials.gov ID
- NCT06152250
- Acronym / sponsor ID
- Profil-NASH / 69HCL22_1059
- Conditions
- Liver Diseases
- Keywords
- intra-hepatic immune responses, liver inflammation, non-alcoholic fatty liver, Non-alcoholic fatty liver disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 29 Jan 2029 (estimated)
- Study completion
- 29 Jan 2029 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Liver Fine-Needle Aspiration, blood sampling and clinical evaluation
| Arm | Type | Receives |
|---|---|---|
| Liver Fine-Needle Aspiration, blood sampling and clinical evaluation | Other | Other: Liver Fine-Needle AspirationAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver Fine-Needle AspirationAt 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. | Other | Liver Fine-Needle Aspiration, blood sampling and clinical evaluation |
Primary outcome
The primary endpoint is the comparison of transcriptomic profiles between NAFL and NASH patients.
Time frame: At the time of the procedure liver biopsy at Day 1
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.
The primary endpoint is the secretome and single-cell phosphoproteome between NAFL and NASH patients.
Time frame: At the time of the procedure liver biopsy at Day 1
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.
The primary endpoint is the immunophenotyping of intrahepatic mononuclear cells between NAFL and NASH patients.
Time frame: At the time of the procedure liver biopsy at Day 1
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.
3 secondary outcomes
Comparison of transcriptome profiles between patients with significant liver fibrosis (≥ F2) and patients without significant fibrosis (F0/F1).
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).
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).
Time frame: At the time of the procedure liver biopsy at Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Fine-Needle Aspiration in people with Liver Diseases, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmina CHOUIK, MD (04.72.07.12.02 ext. +33, yasmina.chouik@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the comparison of transcriptomic profiles between NAFL and NASH patients. (time frame: At the time of the procedure liver biopsy at Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.