Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, Non-cirrhotic liver, Risk factors
Brief summary
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).
Detailed description
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.
Interventions
OTHERBlood test and self-administrated questionnaires
Sponsors
National Cancer Institute, France
University Hospital, Bordeaux
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| exposure to Viral hepatitis B | Baseline | binary yes / undiagnosed by positive serology for anti-HBc antibodies isolated or associated with positive serology for anti-HBs antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| exposure to viral hepatitis C | baseline | binary yes / undiagnosed by positive serology for positive anti-HCV antibodies |
Other
| Measure | Time frame | Description |
|---|---|---|
| history of liver pathology | baseline | binary variable: yes/no |
| Family history of liver cancer | baseline | binary variable: yes/no |
| Diabetes | baseline | categorical variable (depending on the type of diabetes: 1 or 2). |
| Dyslipidemias | baseline | qualitative variables: hypercholesterolemia / hyper triglyceridemia |
| Medical treatments for dyslipidemia | baseline | depending on the type of medication: statins, fibrates, other |
| Metabolic syndrome | baseline | binary variable: present / absent |
| Age of first menstruation | baseline | quantitative variable in years |
| Parity | baseline | number of children |
| exposure to Alcohol | baseline | binary variable, separating large consumers from others |
| Menstrual status | baseline | menopausal status will be treated as a binary variable |
| Duration of exposure to different variables | baseline | quantitative variable in months |
| fruits | baseline | frequency of intake assessed by a frequency food questionnaire |
| vegetables | baseline | frequency of intake assessed by a frequency food questionnaire |
| meat | baseline | frequency of intake assessed by a frequency food questionnaire |
| fish | baseline | frequency of intake assessed by a frequency food questionnaire |
| dairy products | baseline | frequency of intake assessed by a frequency food questionnaire |
| fats | baseline | frequency of intake assessed by a frequency food questionnaire |
| breastfeeding | baseline | binary variable : yes / no |
| exposure to Exogenous female hormones | baseline | oral contraceptive coded as a binary variable |
Countries
France
Outcome results
None listed