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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.

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Sites and contacts
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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
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

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.

Thomas BAUMERT, DR contact

03 68 85 37 03

thomas.baumert@unistra.fr

France1 site, 1 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

    Recruiting

Other trials in France

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 :

  1. / 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.
  2. / 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.

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 groups in NCT04690972
Study groupRoleWhat they receive
Hepato-bilio-pancreatic surgeryPatients whom hepato-bilio-pancreatic surgery is indicated as part of the care
Receives: Procedure: Blood sample during surgery
biopsy of the hepatic parenchymaPatients 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 infectionPatients 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.

  1. 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.

  1. First posted31 Dec 2020
  2. Study start14 Jan 2021
  3. Primary completion18 Jan 2021
  4. Study completion2 Sep 2029 (estimated)

Resources

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)
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

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