"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases". (LivMOD)

December 30, 2020 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population with hepato-bilio-pancratic disease (tumor, viral infection, injury)

Description

Inclusion Criteria:

  1. 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
  2. Patients able to receive and understand information relating to the study and give their written informed consent
  3. Patients affiliated to the French social security system

Exclusion Criteria:

  1. Minor patients
  2. Patients under legal protection,
  3. Patients subject to legal protection or unable to express their consent,
  4. Patients in a situation of social fragility,
  5. Pregnant or breastfeeding woman,
  6. No signing of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepato-bilio-pancreatic surgery
Patients whom hepato-bilio-pancreatic surgery is indicated as part of the care
Procedure: Blood sample during surgery
During the hepato-bilio-pancreatic surgery, blood is drawn.
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
Procedure: Taking an additional biopsy
As part of the treatment, an additional biopsy is executed and blood is drawn.
Other Names:
  • Blood sample during biopsy
Viral chronic infection
Patients with a viral chronic liver disease
Diagnostic test: Blood sample during diagnostic test
Blood sample as part of the care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery for a hepato-bilio-pancreatic issue
Time Frame: through study completion, an average of 8 year
Patients whom hepato-bilio-pancreatic disease
through study completion, an average of 8 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 20, 2020

Primary Completion (ANTICIPATED)

December 20, 2020

Study Completion (ANTICIPATED)

December 4, 2028

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (ACTUAL)

December 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C19-76

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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