Chronic Liver Disease and CirrhosisLivMODNCT04690972
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
An observational study of Chronic Liver Disease and Cirrhosis and Liver Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis, Liver Cancer, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Blood sample during surgery, Taking an additional biopsy and Blood sample during diagnostic test
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 2 Sep 2029
- Phase
- Observational
- 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
Study population: Population with hepato-bilio-pancratic disease (tumor, viral infection, injury)
Who may be able to join
- Patients
- diagnosed with chronic liver disease (viral or not)
- diagnosed with at least one liver nodule for which a biopsy is planned as part of the care
- for hepatobiliary surgery planned as part of care
- for locoregional treatment for HCC is indicated
- Patients able to receive and understand information relating to the study and give their written informed consent
- Patients affiliated to the French social security system
Who cannot join
- Minor patients
- Patients under legal protection,
- Patients subject to legal protection or unable to express their consent,
- Patients in a situation of social fragility,
- Pregnant or breastfeeding woman,
- No signing of informed consent.
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
PU-PH, Directeur de l'UMR_S1110 Unité Inserm d'affiliation : UMR_S1110
Strasbourg, 67000
Thomas BAUMERT, Dr, 03 68 85 37 03, thomas.baumert@unistra.fr
About this study
Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies.
Read the detailed description
The Institute for Research on Viral and Hepatic Diseases, Inserm Unit UMR_S 1110, in Strasbourg, studies hepatic diseases such as non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), cirrhosis and hepatocellular carcinoma (CHC). These diseases can be induced by hepatitis viruses, B (HBV), C (HCV) and D (VHD), but also a poor lifestyle combining overeating and the sedentary lifestyle of our current living patterns.
To date, no treatment is available to cure non-alcoholic steatohepatitis (NASH), cirrhosis, and prevent the development of liver tumors. One of the reasons for the lack of specific treatment is the limited knowledge of the pathophysiology of the liver and the hepatic microenvironment. In addition, the heterogeneity of HCC and associated underlying liver diseases, and the lack of adequate preclinical models are at the root of the difficulties in identifying an effective therapeutic target for these diseases.
Thus, new molecular profiling techniques and strategies are needed to meet these medical needs, in particular the prediction of the response to treatment of HCC, which is still largely unsatisfactory, and the discovery of new therapeutic targets. Using innovative approaches, UMR_S 1110 utilizes single cell RNA sequencing, which is a high resolution technique to analyze gene expression at the individual cell level. This technique represents the most advanced tool for studying heterogeneous tissues such as cancerous tissue.
An in-depth knowledge of HCC and the liver tumor environment at the single-cell level is crucial for understanding the progression of liver disease, for identifying new therapeutic targets and improving clinical outcomes by allowing for estimate the response to treatment and thus improve the patient's vital prognosis, by offering him an adapted personalized treatment. In order to identify factors determining hepatocarcinogenesis, predictors of response to treatment and new therapeutic targets, the investigators propose to analyze tissues from patients with chronic liver disease.
The investigator aim :
- / to establish ex vivo models of chronic hepatic disease and hepatic tumors, in order to study and validate the therapeutic targets identified in the laboratory from single cell RNA sequencing from hepatic tissues obtained from patients. These models include spheroid cultures and models of mice developing liver tumors from xenografts of tumors from patients. To ensure the successful establishment of these complex models, the use of autologous sera is necessary.
- / profile the hepatic tumors and the hepatic tissue adjacent to the tumor, the site of chronic liver disease, using single-cell RNA sequencing in order to study the heterogeneity and complexity of the tumor, to identify novel therapeutic targets and tumor phenotypes that correlate with response to treatment.
Patient-derived preclinical models, developed at unit UMR_S1110, will allow us to better understand the biology of chronic liver disease and liver tumors at the patient level, identify the most appropriate treatment for the patient, and evaluate new treatments and biomarkers to non-invasively diagnose the onset of liver disease, for the benefit of personalized medicine for the benefit of the patient.
Blood samples obtained from patients with chronic liver disease will also allow us to:
- Advance knowledge on viral hepatitis, in particular HCV, HBV and HDV;
- Implement new strategies for the development of a vaccine for HCV;
- Identify new biomarkers of hepatic carcinogenesis by comparing the metabolomic and inflammatory profiles of patients.
The partnership between Inserm, the University of Strasbourg and the University Hospitals of Strasbourg makes it possible to create unique synergies that will ultimately help identify new targets for therapeutic and preventive strategies against these diseases which represent a major public health problem.
- Conditions
- Chronic Liver Disease and Cirrhosis, Liver Cancer, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis, Viral Hepatitis B, Viral Hepatitis C
- Being tested
- Blood sample during surgery, Taking an additional biopsy, Blood sample during diagnostic test
- Keywords
- Liver disease, Ex vivo models, Single cell, Biomarkers, Spheroïds
- Medical subject headings
- Fibrosis, Liver Neoplasms, Non-alcoholic Fatty Liver Disease, Hepatitis B, Hepatitis C, Hepatitis D, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample during surgeryProcedure or surgery
During the hepato-bilio-pancreatic surgery, blood is drawn.
Taking an additional biopsyProcedure or surgery
Also called Blood sample during biopsy
As part of the treatment, an additional biopsy is executed and blood is drawn.
Blood sample during diagnostic testDiagnostic test
Blood sample as part of the care
| Study group | Role | What they receive |
|---|---|---|
| Hepato-bilio-pancreatic surgery | Patients whom hepato-bilio-pancreatic surgery is indicated as part of the care Receives: Procedure: Blood sample during surgery | |
| biopsy of the hepatic parenchyma | Patients whom a biopsy of the hepatic parenchyma, one or more hepatic nodules or a loco-regional treatment is indicated as part of the care Receives: Procedure: Taking an additional biopsy | |
| Viral chronic infection | Patients with a viral chronic liver disease Receives: Diagnostic Test: Blood sample during diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery for a hepato-bilio-pancreatic issue
Patients whom hepato-bilio-pancreatic disease
Measured: through study completion, an average of 8 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start14 Jan 2021
- Primary completion18 Jan 2021
- Study completion2 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690972
- Sponsor's protocol ID
- C19-76
- Acronym
- LivMOD
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crouchet E, Almeida N, Durand SC, Parnot M, Oudot MA, Giannone F, Gadenne C, Roehlen N, Saviano A, Felli E, Pessaux P, Duong HT, Ohdan H, Aikata H, Chayama K, Baumert TF, Schuster C. A patient-derived HCC spheroid system to model the tumor microenvironment and treatment response. JHEP Rep. 2024 Oct 28;7(2):101252. doi: 10.1016/j.jhepr.2024.101252. eCollection 2025 Feb.
PubMed 39897611
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
- ClinicalTrials.gov ID
- NCT04690972
- Acronym / sponsor ID
- LivMOD / C19-76
- Conditions
- Chronic Liver Disease and Cirrhosis, Liver Cancer, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis, Viral Hepatitis B, Viral Hepatitis C
- Keywords
- Liver disease, Ex vivo models, Single cell, Biomarkers, Spheroïds
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 2 Sep 2029 (estimated)
- First posted
- 31 Dec 2020 (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.
Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies.
Detailed description
The Institute for Research on Viral and Hepatic Diseases, Inserm Unit UMR_S 1110, in Strasbourg, studies hepatic diseases such as non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), cirrhosis and hepatocellular carcinoma (CHC). These diseases can be induced by hepatitis viruses, B (HBV), C (HCV) and D (VHD), but also a poor lifestyle combining overeating and the sedentary lifestyle of our current living patterns.
To date, no treatment is available to cure non-alcoholic steatohepatitis (NASH), cirrhosis, and prevent the development of liver tumors. One of the reasons for the lack of specific treatment is the limited knowledge of the pathophysiology of the liver and the hepatic microenvironment. In addition, the heterogeneity of HCC and associated underlying liver diseases, and the lack of adequate preclinical models are at the root of the difficulties in identifying an effective therapeutic target for these diseases.
Thus, new molecular profiling techniques and strategies are needed to meet these medical needs, in particular the prediction of the response to treatment of HCC, which is still largely unsatisfactory, and the discovery of new therapeutic targets. Using innovative approaches, UMR_S 1110 utilizes single cell RNA sequencing, which is a high resolution technique to analyze gene expression at the individual cell level. This technique represents the most advanced tool for studying heterogeneous tissues such as cancerous tissue.
An in-depth knowledge of HCC and the liver tumor environment at the single-cell level is crucial for understanding the progression of liver disease, for identifying new therapeutic targets and improving clinical outcomes by allowing for estimate the response to treatment and thus improve the patient's vital prognosis, by offering him an adapted personalized treatment. In order to identify factors determining hepatocarcinogenesis, predictors of response to treatment and new therapeutic targets, the investigators propose to analyze tissues from patients with chronic liver disease.
The investigator aim :
- / to establish ex vivo models of chronic hepatic disease and hepatic tumors, in order to study and validate the therapeutic targets identified in the laboratory from single cell RNA sequencing from hepatic tissues obtained from patients. These models include spheroid cultures and models of mice developing liver tumors from xenografts of tumors from patients. To ensure the successful establishment of these complex models, the use of autologous sera is necessary.
- / profile the hepatic tumors and the hepatic tissue adjacent to the tumor, the site of chronic liver disease, using single-cell RNA sequencing in order to study the heterogeneity and complexity of the tumor, to identify novel therapeutic targets and tumor phenotypes that correlate with response to treatment.
Patient-derived preclinical models, developed at unit UMR_S1110, will allow us to better understand the biology of chronic liver disease and liver tumors at the patient level, identify the most appropriate treatment for the patient, and evaluate new treatments and biomarkers to non-invasively diagnose the onset of liver disease, for the benefit of personalized medicine for the benefit of the patient.
Blood samples obtained from patients with chronic liver disease will also allow us to:
- Advance knowledge on viral hepatitis, in particular HCV, HBV and HDV;
- Implement new strategies for the development of a vaccine for HCV;
- Identify new biomarkers of hepatic carcinogenesis by comparing the metabolomic and inflammatory profiles of patients.
The partnership between Inserm, the University of Strasbourg and the University Hospitals of Strasbourg makes it possible to create unique synergies that will ultimately help identify new targets for therapeutic and preventive strategies against these diseases which represent a major public health problem.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hepato-bilio-pancreatic surgery | – | Procedure: Blood sample during surgeryPatients whom hepato-bilio-pancreatic surgery is indicated as part of the care |
| biopsy of the hepatic parenchyma | – | Procedure: Taking an additional biopsyPatients whom a biopsy of the hepatic parenchyma, one or more hepatic nodules or a loco-regional treatment is indicated as part of the care |
| Viral chronic infection | – | Diagnostic Test: Blood sample during diagnostic testPatients with a viral chronic liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with hepato-bilio-pancratic disease (tumor, viral infection, injury)
Key inclusion criteria (7 listed)
- Patients
- Patients able to receive and understand information relating to the study and give their written informed consent
- Patients affiliated to the French social security system
Key exclusion criteria (6 listed)
- Minor patients
- Patients under legal protection,
- Patients subject to legal protection or unable to express their consent,
- Patients in a situation of social fragility,
- Pregnant or breastfeeding woman,
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 |
|---|---|---|
| Blood sample during surgeryDuring the hepato-bilio-pancreatic surgery, blood is drawn. | Procedure or surgery | Hepato-bilio-pancreatic surgery |
| Taking an additional biopsyAlso: Blood sample during biopsyAs part of the treatment, an additional biopsy is executed and blood is drawn. | Procedure or surgery | biopsy of the hepatic parenchyma |
| Blood sample during diagnostic testBlood sample as part of the care | Diagnostic test | Viral chronic infection |
Primary outcome
Surgery for a hepato-bilio-pancreatic issue
Time frame: through study completion, an average of 8 year
Patients whom hepato-bilio-pancreatic disease
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 22 Oct 2026.
- Results publication: PubMed 39897611Crouchet E, Almeida N, Durand SC, Parnot M, Oudot MA, Giannone F, Gadenne C, Roehlen N, Saviano A, Felli E, Pessaux P, Duong HT, Ohdan H, Aikata H, Chayama K, Baumert TF, Schuster C. A patient-derived HCC spheroid system to model the tumor microenvironment and treatment response. JHEP Rep. 2024 Oct 28;7(2):101252. doi: 10.1016/j.jhepr.2024.101252. eCollection 2025 Feb.
Related trials for Chronic Liver Disease and Cirrhosis
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
RecruitingObservational study
Natural History of Advanced Chronic Liver Diseases
Cirrhosis, Advanced Chronic Liver Disease
Recruiting
HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
Cirrhosis, End Stage Liver DIsease
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?
An observational study of Chronic Liver Disease and Cirrhosis and Liver Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France 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 7 inclusion and 6 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 22 Oct 2026. 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 Thomas BAUMERT, DR (03 68 85 37 03, thomas.baumert@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery for a hepato-bilio-pancreatic issue (time frame: through study completion, an average of 8 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690972, which also lists 1 linked publication.
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 22 Oct 2026.