跳至主要内容
临床试验/NCT04690972
NCT04690972招募中不适用

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

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2021年1月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
1
主要终点
Surgery for a hepato-bilio-pancreatic issue

研究概览

简要总结

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.

详细描述

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 :

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Viral chronic infection

Patients with a viral chronic liver disease

干预措施: Blood sample during diagnostic test (Diagnostic Test)

Hepato-bilio-pancreatic surgery

Patients whom hepato-bilio-pancreatic surgery is indicated as part of the care

干预措施: Blood sample during surgery (Procedure)

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

干预措施: Taking an additional biopsy (Procedure)

结局指标

主要结局

Surgery for a hepato-bilio-pancreatic issue

时间窗: through study completion, an average of 8 year

Patients whom hepato-bilio-pancreatic disease

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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