CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 710
- 试验地点
- 1
- 主要终点
- Primary outcome measure CHALNA2
研究概览
简要总结
The aim is to determine the metabolic factors, host immune factors, and medical imaging data associated with the development of HepatoCellular Carcinoma (HCC) in patients with alcohol-related liver disease or dysmetabolic steatosis/Non-Alcoholic SteatoHepatitis.
The investigators will include patients with and without cirrhosis in order to identify early molecular mechanisms involved in the development of HCC especially in non-cirrhotic patients.
详细描述
Type and methodology of the research:
Within the framework of the usual management of the patient's pathology, a clinico-biological characterization (dietary and physical activity questionnaires, "performans status", anthropometric measurements, usual blood biology characterizing the hepatic, renal and inflammatory function, the carbohydrate and lipid metabolism, the non invasive test for liver fibrosis ELF etc.) will be carry out. In order to collect radiomic data, liver imaging (particularly in case of HCC) will be done.
A liver biopsy and constitution of a biobank (samples of plasma, sera, DNA and leucocyte pellets) will be performed.
The elements necessary for the classification of possible hepatocellular carcinomas (BCLC classification) will be collected.
Anticipated research schedule:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria common to all patients:
- •Affiliation to French social security.
- •Male or female ≥ 18 years of age
- •Patients able to receive and understand information about the research and to give written informed consent duly signed by the patient and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).
- •Patients in the NAFLD group with HCC:
- •Alcohol consumption ≤ 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and ≤ 20 g pure alcohol/d (140 g pure alcohol/week) for women.
- •Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine.
- •No systemic treatment for HCC within 6 months prior to inclusion.
- •Patients in the NAFLD group without HCC:
- •Alcohol consumption ≤ 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and ≤ 20 g pure alcohol/d (140 g pure alcohol/week) for women.
- •Decision of less than 3 months of a liver biopsy performed as a clinical routine. Biopsy will be motivated by liver function disturbance(s) and/or ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and/or fibrosis in some of these patients.
- •Patients in the alcohol-related liver disease group with HCC:
- •Alcohol consumption > 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and > 20 g pure alcohol/d (140 g pure alcohol/week) or binge drinking
- •Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine
- •No systemic treatment for HCC within 6 months prior to inclusion.
- •Patients in the alcohol-related liver disease group without HCC:
- •Alcohol consumption > 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and > 20 g pure alcohol/d (140 g pure alcohol/week) or binge drinking
- •Decision of less than 3 months for a liver biopsy to be performed as a clinical routine. Biopsy will be motivated by liver balance disturbance(s) and/or ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and/or fibrosis in some of these patients.
排除标准
- •Positive HIV serology
- •Patients with detectable hepatitis C viral load
- •Presence of Hbs antigen
- •History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency
- •Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus
- •History of solid organ transplantation or bone marrow transplantation
- •Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma)
- •Patients under legal protection or unable to express their consent,
- •Pregnant or breastfeeding women
研究组 & 干预措施
Descriptive study
The patients included in this observational study are patients with hepatic steatosis either related to NAFLD or to alcohol-related liver disease.
Patients included in the study may have hepatocellular carcinoma.
Thus, 4 groups of patients can be recruited:
- patients with NAFLD without hepatocellular carcinoma,
- patients with NAFLD with hepatocellular carcinoma,
- patients with alcohol-related liver disease without hepatocellular carcinoma, -patients with alcohol-related liver disease with hepatocellular carcinoma.
干预措施: Liver biopsy (Diagnostic Test)
结局指标
主要结局
Primary outcome measure CHALNA2
时间窗: 2022-2032
The primary endpoint will be the study of variations in metabolic gene markers (i.e. mRNA of genes implicated in inflammation or metabolism assessed in qPCR, using a housekeeping gene such as glyceraldehyde-3-phosphate dehydrogenase (GAPDH)), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage.
次要结局
- Secondary outcome measure CHALNA2(2022-2032)
- 3th outcome measure CHALNA2(2022-2032)
- 5th outcome measure CHALNA2(2022-2032)
- 4th outcome measure CHALNA2(2022-2032)
- 6th outcome measure CHALNA2(2022-2032)
- 7th outcome measure CHALNA2(2022-2032)