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Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study) (NoFlic)

2019年2月21日 更新者：University Hospital, Bordeaux

Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver (NoFlic Study)

The main objective of this study is to identify direct carcinogenic factors in the absence of cirrhosis, and the carcinogenesis pathways involved on nonfibrotic liver (NfCHC).

研究概览

地位

完全的

条件

干预/治疗

详细说明

Most hepatocellular carcinoma (HCC) complicates cirrhosis, which is often caused by infection with hepatitis B or C viruses, alcohol, obesity, exposure to aflatoxin B1 (AFB1) or hemochromatosis. Nevertheless, 10 to 40% of HCCs can develop on non-cirrhotic terrain and about 5% on nonfibrotic liver (NfHCC). In 20 to 40% of these NfHCCs, no classical HCC risk factor is identified. Some cases could be the result of a transformation of an adenoma. Others may be associated with yet non-formally identified toxins and / or a specific genetic predisposition. While there is a lot of data on alterations of signaling pathways (ß-catenin, AKT / mTOR, Ras / pERK, etc.) in "classical" HCCs, altered pathways remain unknown in most NfHCCs, even in some cases, activation of β-catenin, inactivating mutations of HNF1 or activators of gp130 have been shown. A specific study of NfHCCs, rather rare cancers, represents an opportunity to look for directly carcinogenic factors in the absence of cirrhosis, and to dissect the involved carcinogenesis pathways.

研究类型

观察性的

注册 (实际的)

283

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Amiens、法国
        • CHU Amiens
      • Bondy、法国
        • AP-HP Jean Verdier
      • Bordeaux、法国
        • CHU Bordeaux
      • Caen、法国
        • CHU Caen
      • Clamart、法国
        • AP-HP Hôpital Antoine Beclere
      • Clichy、法国
        • AP-HP Hôpital Beaujon
      • Créteil、法国
        • Chi Creteil
      • Grenoble、法国
        • Chu Grenoble
      • Lyon、法国
        • Hôpital Edouard Herriot
      • Lyon、法国
        • Hospices Civiles de Lyon
      • Paris、法国
        • Ap-Hp Cochin
      • Paris、法国
        • AP-HP Hopital Saint Antoine
      • Paris、法国
        • AP-HP Hopital Henri Mondor
      • Villejuif、法国
        • CHU Villejuif

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

CASES: patients with a diagnosis of NfHCC with anatomopathological examination and showing a HCC according to standard histopathological criteria and an absence of significant fibrosis in non-tumoral tissues with the METAVIR system score or equivalent (F0 or F1) or the Kleiner et al stage of ASH and NASH (≤stade 2)

- CONTROLS: patients without NfHCC at baseline

描述

Inclusion Criteria:

  • CASES: patients aged 18 years and older with a diagnosis of NfHCC with anatomopathological examination and showing a HCC according to standard histopathological criteria and an absence of significant fibrosis in non-tumoral tissues with the METAVIR system score or equivalent (F0 or F1) or the Kleiner et al stage of ASH and NASH (≤stade 2); signed informed consent; affiliated or beneficiary of a social security system
  • CONTROLS: patients aged 18 years and older without NfHCC at baseline; patients for whom an endoscopy is programmed as part of an assessment of intestinal functional disorders, dyspeptic disorders or screening colonoscopy or hospitalized patients in orthopedic surgery / traumatology or rheumatology departments; signed informed consent; affiliated or beneficiary of a social security system

Exclusion Criteria:

  • CASES: HCC diagnosed without pathological examination; hepatic transplantation before the diagnosis of HCC; patients unable to answer questions; patients who do not speak French or live abroad.
  • CONTROLS: History of liver cancer; other cancers under treatment except cutaneous cancers; Colonoscopy indicated in case of familial form of colon cancer; patient with cirrhosis; patients unable to answer questions; patients who do not speak French or live abroad; Relationship or same home with the case

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Cases: patients with hepatocellular carcinoma on non-cirrhotic
Blood test and self-administrated questionnaires (medical history of the participant and his / her family, tobacco consumption, alcoholic and non-alcoholic beverages consumption, eating habits, type of employment and exposure, stays abroad longer than 1 month
Control: patients without hepatocellular carcinoma
Blood test and self-administrated questionnaires (medical history of the participant and his / her family, tobacco consumption, alcoholic and non-alcoholic beverages consumption, eating habits, type of employment and exposure, stays abroad longer than 1 month
其他：Blood test and self-administrated questionnaires

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
exposure to Viral hepatitis B
大体时间：Baseline
binary yes / undiagnosed by positive serology for anti-HBc antibodies isolated or associated with positive serology for anti-HBs antibodies
Baseline

次要结果测量

结果测量
措施说明
大体时间
exposure to viral hepatitis C
大体时间：baseline
binary yes / undiagnosed by positive serology for positive anti-HCV antibodies
baseline

其他结果措施

结果测量
措施说明
大体时间
exposure to Alcohol
大体时间：baseline
binary variable, separating large consumers from others
baseline
exposure to Exogenous female hormones
大体时间：baseline
oral contraceptive coded as a binary variable
baseline
history of liver pathology
大体时间：baseline
binary variable: yes/no
baseline
Family history of liver cancer
大体时间：baseline
binary variable: yes/no
baseline
Diabetes
大体时间：baseline
categorical variable (depending on the type of diabetes: 1 or 2).
baseline
Dyslipidemias
大体时间：baseline
qualitative variables: hypercholesterolemia / hyper triglyceridemia
baseline
Medical treatments for dyslipidemia
大体时间：baseline
depending on the type of medication: statins, fibrates, other
baseline
Metabolic syndrome
大体时间：baseline
binary variable: present / absent
baseline
Age of first menstruation
大体时间：baseline
quantitative variable in years
baseline
Parity
大体时间：baseline
number of children
baseline
breastfeeding
大体时间：baseline
binary variable : yes / no
baseline
Menstrual status
大体时间：baseline
menopausal status will be treated as a binary variable
baseline
Duration of exposure to different variables
大体时间：baseline
quantitative variable in months
baseline
fruits
大体时间：baseline
frequency of intake assessed by a frequency food questionnaire
baseline
vegetables
大体时间：baseline
frequency of intake assessed by a frequency food questionnaire
baseline
meat
大体时间：baseline
frequency of intake assessed by a frequency food questionnaire
baseline
fish
大体时间：baseline
frequency of intake assessed by a frequency food questionnaire
baseline
dairy products
大体时间：baseline
frequency of intake assessed by a frequency food questionnaire
baseline
fats
大体时间：baseline
frequency of intake assessed by a frequency food questionnaire
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Bordeaux

合作者

National Cancer Institute, France

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年8月18日

初级完成 (实际的)

2013年11月14日

研究完成 (实际的)

2013年11月14日

研究注册日期

首次提交

2019年1月31日

首先提交符合 QC 标准的

2019年2月21日

首次发布 (实际的)

2019年2月25日

研究记录更新

最后更新发布 (实际的)

2019年2月25日

上次提交的符合 QC 标准的更新

2019年2月21日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CHUBX 2010/03

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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